19 results on '"Regan JJ"'
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2. Revision and explantation strategies involving the CHARITE lumbar artificial disc replacement.
- Author
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Leary SP, Regan JJ, Lanman TH, and Wagner WH
- Abstract
STUDY DESIGN: A large case series of anterior revision surgery in patients who had complications following lumbar total disc replacement with the CHARITE artificial disc. OBJECTIVES: To analyze and discuss the etiology of implant-related complications and to present a strategy that can be applied to lumbar intervertebral disc prostheses in cases where anterior revision surgery is necessary. SUMMARY OF BACKGROUND DATA: This report represents the largest single-site, consecutive case series reported in the literature of anterior revision surgery following lumbar disc arthroplasty. METHODS: A total of 18 patients are included in this study. All patients required an anterior revision procedure for repositioning or removal of the prosthesis. The mean time to revision was 6 months (range, 9 days to 4 years). RESULTS: In 17 of 20 cases, implant removal was required and the patient was converted to a fusion. In 3 cases, primary revision of the CHARITE artificial disc was performed. Six revision cases were performed within the early postoperative period, defined as 7 to 14 days. All early cases were approached via reexploration of the original anterior midline retroperitoneal incision. Late revision was required in 14 cases, ranging from 3 weeks to 4 years following initial arthroplasty. A variety of surgical approaches were used in late revisions, including the lateral transpsoas approach at L3-L4 or L4-L5 (n = 5), expanded ipsilateral left retroperitoneal approach at L4-L5 (n = 2), contralateral right retroperitoneal approach at L5-S1 (n = 6), and transperitoneal approach (n = 1). Following 20 consecutive, anterior revision procedures, implant revision was successfully achieved in all cases. CONCLUSIONS: Total disc replacement implant revisions occur largely as a result of technical errors in positioning and sizing of the implant. In addition, adherence to strict patient selection criteria will eliminate many cases of implant failure. When necessary, anterior revision surgery can be performed safely when a strategic approach is used. [ABSTRACT FROM AUTHOR]
- Published
- 2007
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3. Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charité Artificial Disc.
- Author
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Regan JJ, McAfee PC, Blumenthal SL, Guyer RD, Geisler FH, Garcia R Jr., and Maxwell JH
- Abstract
STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. OBJECTIVES: To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study. SUMMARY OF BACKGROUND DATA: To our knowledge, an analysis of the effect of surgical volume has not been performed for any spine surgical procedure. Prior reports of the early experience with lumbar total disc replacement consist of retrospective reviews with nonspecific indications. METHODS: An analysis was performed of the Food and Drug Administration IDE Study of the Charité Artificial Disc (DePuy Spine, Inc., Raynham, MA). Patients enrolled in the control group were omitted from the analysis. Up to 5 nonrandomized cases (representing the early experience) were performed at each site before beginning the randomized arm of the study. There were 3 comparisons performed: nonrandomized cases (71) versus randomized cases (205); randomized cases performed by high-enrolling surgeons versus low-enrolling surgeons; and randomized cases at high-volume institutions versus low-volume institutions. RESULTS: The high-enrolling groups had a significantly lower mean hospital stay and operating time compared to the low-enrolling groups (P < 0.05). High-enrolling surgeons and institutions showed significantly shorter operating times, length of hospital stay, and complication rates. High-enrolling surgeons had significantly fewer device failures and cases of neurologic deterioration. Mean operating time and hospital stay were significantly lower in the randomized group (P < 0.05) compared to the nonrandomized group. Blood loss and approach-related complications were similar between the 2 groups. Device failure requiring removal was 4.2% in the nonrandomized group and 1.5% in the randomized group. CONCLUSIONS: Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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4. Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc.
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McAfee PC, Geisler FH, Saiedy SS, Moore SV, Regan JJ, Guyer RD, Blumenthal SL, Fedder IL, Tortolani PJ, Cunningham B, McAfee, Paul C, Geisler, Fred H, Saiedy, Samer S, Moore, Sandra V, Regan, John J, Guyer, Richard D, Blumenthal, Scott L, Fedder, Ira L, Tortolani, P Justin, and Cunningham, Bryan
- Published
- 2006
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5. Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial.
- Author
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McAfee PC, Cappuccino A, Cunningham BW, Devine JG, Phillips FM, Regan JJ, Albert TJ, and Ahrens JE
- Subjects
- Adult, Arthroplasty statistics & numerical data, Cervical Vertebrae pathology, Cervical Vertebrae surgery, Diskectomy statistics & numerical data, Female, Humans, Incidence, Internal Fixators adverse effects, Intervertebral Disc pathology, Intervertebral Disc surgery, Intervertebral Disc Displacement pathology, Intervertebral Disc Displacement physiopathology, Intervertebral Disc Displacement surgery, Male, Middle Aged, Outcome Assessment, Health Care, Prospective Studies, Radiculopathy pathology, Radiculopathy physiopathology, Radiculopathy surgery, Spinal Cord Compression pathology, Spinal Cord Compression physiopathology, Spinal Cord Compression surgery, Spinal Fusion statistics & numerical data, Spondylosis pathology, Spondylosis physiopathology, Treatment Outcome, Arthroplasty adverse effects, Deglutition Disorders epidemiology, Diskectomy adverse effects, Postoperative Complications epidemiology, Spinal Fusion adverse effects, Spondylosis surgery
- Abstract
Study Design: The current study of 251 consecutive 1-level anterior cervical reconstructions was undertaken to compare the incidence of dysphagia between cervical disk replacement and conventional anterior cervical fusion and instrumentation., Objectives: This is a report of 251 patients from 5 investigational centers in the Food and drug Administration's prospective, randomized porous-coated motion (PCM) trial using a validated dysphagia outcomes instrument. The dysphagia data for both PCM and anterior cervical diskectomy and fusion (ACDF) patients were reviewed from 5 centers to (1) compare the severity of dysphagia, (2) compare the postoperative incidence of dysphagia, and (3) to compare the resolution of perioperative dysphagia., Summary of Background Data: Dysphagia and dysphonia after anterior surgical approaches to the cervical spine have been previously reported. The current prospective, randomized investigation quantifies clinical dysphagia based on 3 criteria-severity, incidence, and resolution-in a time-course evaluation., Methods: Patients between 18 and 65 years with 1-level symptomatic cervical radiculopathy and/or myelopathy for progressive neurologic symptoms, were randomized to undergo anterior decompression and PCM arthroplasty (N=151) or ACDF (control) (N=100). Patients self-reported dysphagia severity using the Bazaz scale preoperatively and at follow-up. The Bazaz scale has 4 classes of severity based upon the problems with swallowing that the patient has with both liquids and solids., Results: The Bazaz results demonstrate that although both the PCM and ACDF groups exhibited an initial postoperative problem with swallowing, the PCM group continued to improve with increasing time after implantation, whereas the ACDF only improved minimally. The PCM treatments indicated significantly lower incidence of dysphagia at 3 and 12 months postoperatively compared with ACDF controls (P<0.05). An increase in dysphagia severity at either the 6-week or 3-month follow-up visit was reported in 35 (42%) PCM and 29 (64%) ACDF subjects. Long-term resolution of these symptoms was noted in 74% (26/35) of the PCM subjects as compared with 41.4% (12/29) of the ACDF subjects (P=0.015)., Conclusions: In a prospective randomized clinical study the incidence of postoperative dysphagia and the long-term resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.
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- 2010
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6. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes.
- Author
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Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, and Ohnmeiss DD
- Subjects
- Adult, Disability Evaluation, Employment, Female, Follow-Up Studies, Humans, Intervertebral Disc Displacement diagnostic imaging, Low Back Pain drug therapy, Low Back Pain surgery, Lumbar Vertebrae diagnostic imaging, Male, Middle Aged, Narcotics administration & dosage, Pain Measurement, Patient Satisfaction, Prospective Studies, Prosthesis Design, Radiography, Treatment Outcome, United States, United States Food and Drug Administration, Intervertebral Disc, Intervertebral Disc Displacement surgery, Lumbar Vertebrae surgery, Prostheses and Implants, Spinal Fusion
- Abstract
Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial., Objectives: The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment., Summary of Background Data: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes., Methods: Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITE artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey., Results: Patients in both groups improved significantly following surgery. Patients in the CHARITE artificial disc group recovered faster than patients in the control group. Patients in the CHARITE artificial disc group had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITE artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITE artificial disc group (P < 0.05). The complication rate was similar between both groups., Conclusions: This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.
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- 2005
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7. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes.
- Author
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McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, and Isaza J
- Subjects
- Adult, Female, Follow-Up Studies, Humans, Intervertebral Disc Displacement diagnostic imaging, Lumbar Vertebrae diagnostic imaging, Lumbar Vertebrae physiology, Male, Middle Aged, Movement, Prospective Studies, Prosthesis Implantation methods, Radiography, Range of Motion, Articular, Treatment Outcome, United States, United States Food and Drug Administration, Intervertebral Disc, Intervertebral Disc Displacement surgery, Lumbar Vertebrae surgery, Prostheses and Implants, Prosthesis Implantation standards, Spinal Fusion
- Abstract
Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated, investigational device exemption clinical trial., Objectives: To compare the safety and effectiveness of lumbar total disc replacement (TDR) with the CHARITE artificial disc (DePuy Spine, Raynham, MA) to anterior lumbar interbody fusion for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. In addition, to evaluate the radiographic outcomes of lumbar artificial disc replacement at either L4-L5 or L5-S1 with the CHARITE artificial disc as compared to anterior lumbar interbody fusion with cylindrical cages and iliac crest bone graft; and to determine if a correlation exists between clinical outcomes and surgical accuracy of TDR placement within the disc space., Summary of Background Data: Prior investigators have reported excellent radiographic results with the CHARITE artificial disc for the treatment of lumbar degenerative disc disease. These encouraging results are the product of retrospective reviews without a control. Very few studies have reported on the segmental motion of an intervertebral level implanted with an artificial disc, and no studies have reported a correlation of radiographic and clinical outcomes., Methods: A prospective, randomized, multicenter, US Food and Drug Administration, investigational device exemption study with 24-month follow-up was performed at 14 centers throughout the United States. A total of 304 subjects were randomized in a 2:1 ratio, with 205 in the investigational group (TDR with the CHARITE artificial disc) and 99 in the control group (anterior lumbar interbody fusion with BAK cages and iliac crest bone graft). A total of 71 TDR training cases were performed (up to 5 at each site) before randomization beginning at each site. Plain radiographs were analyzed for each subject in both groups regarding range of motion (ROM) in flexion/extension, restoration of disc space height, and subsidence. Prosthesis placement in the coronal and midsagittal planes was analyzed for the 276 patients with TDR. Correlations were performed between prosthesis placement and clinical outcomes., Results: Patients in the investigational group had a 13.6% mean increase, and those in the control group an 82.5% decrease in mean flexion/extension ROM at 24 months postoperatively compared to baseline. Patients in the investigational group had significantly better restoration of disc height than the control group (P < 0.05). There was significantly less subsidence in the investigational group compared to the control group (P < 0.05). The surgical technical accuracy of CHARITE artificial disc placement was divided into 3 groups: I, ideal (83%); II, suboptimal (11%); and III, poor (6%), and correlated with clinical outcomes. The flexion/extension ROM and prosthesis function improved with the surgical technical accuracy of radiographic placement (P = 0.003)., Conclusions: Preoperative ROM in flexion/extension was restored and maintained in patients receiving a TDR. TDR with the CHARITE artificial disc resulted in significantly better restoration of disc space height, and significantly less subsidence than anterior interbody fusion with BAK cages. Clinical outcomes and flexion/extension ROM correlated with surgical technical accuracy of CHARITE artificial disc placement. In the majority of cases, placement of the CHARITE artificial disc was ideal.
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- 2005
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8. Endoscopic lateral transpsoas approach to the lumbar spine.
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Bergey DL, Villavicencio AT, Goldstein T, and Regan JJ
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- Adult, Aged, Endoscopes, Female, Humans, Lumbar Vertebrae diagnostic imaging, Lumbar Vertebrae pathology, Magnetic Resonance Imaging, Male, Middle Aged, Minimally Invasive Surgical Procedures, Postoperative Complications, Psoas Muscles surgery, Radiography, Endoscopy methods, Lumbar Vertebrae surgery, Spinal Fusion methods
- Abstract
Study Design: A description of a novel surgical approach to the lumbar spine and a prospective evaluation of the early surgical outcomes., Objectives: Describe the early postoperative results and the operative technique of a new, minimally invasive transpsoas approach for anterior fusion of the lumbar spine that minimizes the risk to large vessels and other critical structures., Summary of Background Data: Standard anterior endoscopic approaches to the lumbar spine require mobilization of the great vessels and sympathetic plexus. Vascular injury and retrograde ejaculation are complications clearly associated with this approach. A retroperitoneal, transpsoas approach to the lumbar spine may reduce these risks., Methods: From 1996 to 2002, 21 patients (13 females, 8 males; mean age 50.0 years) underwent an endoscopic, retroperitoneal transpsoas approach for exposure of the lumbar spine. Surgical indications included discogenic pain in 14 patients, spinal instability at a level adjacent to a previous fusion in 3 patients, and progressive degenerative scoliosis in 4 patients. Data were reviewed to document the early postoperative results for this procedure. Illustrations were created to clearly describe this approach., Results: Average operative time for the single level cases was 149 minutes (range 120-170 minutes); blood loss was 150 cc (range 50-650); postoperative hospital stay was 4.1 days. At long-term follow-up, visual analogue scale scores had decreased an average of 5.9. Mean follow-up was 3.1 years (range 2 months-6.0 years). Six patients (30%) experienced paresthesias in the groin/thigh region. Five of these same patients also complained of groin/thigh pain (27%). Two patients had symptoms that lasted longer than 1 month. One patient was converted to a mini-open lateral approach. There were no vascular injuries., Conclusions: Early results show the endoscopic lateral transpsoas approach to the lumbar spine to be a safe, minimally invasive method for anterior fusion of the first through the fourth lumbar vertebrae. Although there is a risk of groin/thigh numbness or pain, and these symptoms are mostly transient. This approach allows for exposure of the lumbar spine without mobilization of the great vessels or sympathetic plexus.
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- 2004
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9. Video-assisted thoracoscopic surgery for thoracic disc disease: Classification and outcome study of 100 consecutive cases with a 2-year minimum follow-up period.
- Author
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Anand N and Regan JJ
- Subjects
- Adult, Aged, Disability Evaluation, Diskectomy adverse effects, Diskectomy statistics & numerical data, Female, Follow-Up Studies, Humans, Intervertebral Disc Displacement diagnosis, Male, Middle Aged, Patient Satisfaction statistics & numerical data, Prospective Studies, Reoperation statistics & numerical data, Spinal Fusion statistics & numerical data, Treatment Outcome, Diskectomy instrumentation, Intervertebral Disc Displacement classification, Intervertebral Disc Displacement surgery, Thoracic Surgery, Video-Assisted adverse effects
- Abstract
Study Design: Prospectively collected data from regular clinical follow-up evaluations were tabulated, analyzed, reviewed using a patient self-reported questionnaire., Objective: To develop a classification system and present the long-term functional outcome of video-assisted thorascopic surgery for refractory thoracic disc disease., Summary of Background Data: Recent studies have found an 11.1% to 14.5% prevalence of thoracic disc herniations. Surgical approaches have included laminectomy, pediculectomy, costotransversectomy, lateral extracavitary, transverse arthropediculectomy, transthoracic-transpleural thoracotomy, and thoracoscopy. Recent reports have documented encouraging early results with video-assisted thorascopic surgery for thoracic disc herniations. Comparisons between thoracoscopy and open thoracotomy have demonstrated improvement in postoperative pain and morbidity with the use of endoscopic techniques., Methods: This study included 100 consecutive patients (45 women and 55 men) with an average follow-up evaluation of 4 years (range, 2-6 years). The average age of the patients was 42 years (range, 22-76 years). The average duration of symptoms was 26 months (range, 6-96 months), and 18 patients had undergone prior spine surgery. Patients were graded as follows according to the presenting symptoms (Table 1): Grade 1 (pure axial; n = 28), Grade 2 (pure radicular; n = 5), Grade 3A (axial and thoracic radicular; n = 38), Grade 3B (axial with lower leg pain; n = 19), Grade 4 (myelopathic; n = 8), or Grade 5 (paralytic = 2)., Results: A total of 117 discs were excised in 100 patients. Of the 40 patients who underwent fusion, 27 had autologous rib struts and 13 had threaded fusion. The mean operative time was 173 minutes, blood loss 259 mL, average ICU stay less than 1 day, and average hospital stay 4 days. Minor complications occurred in 21 patients, all of which resolved with no untoward effect. No patient's neurologic status worsened. Four patients underwent a secondary fusion, and a pseudarthrosis developed in one patient. Clinical success was defined objectively as an improvement in Oswestry score of 20% or more at 2 years and at final follow-up assessment, as compared with the preoperative Oswestry score. Overall, objective clinical success was observed at 2 years in 73% of the patients, and at final follow-up assessment in 70% of patients. The average percentage of improvement in Oswestry scores was most marked in Grade 4 patients (myelopathy; 60%), followed by Grade 3A patients (axial and thoracic radicular pain; 37%), Grade 3B patients (axial with leg pain; 28%), and Grade 1 patients (pure axial; 24%). The Oswestry disability score (Table 2) and back pain visual analog score (Table 3) also were significantly improved (P < 0.05) at 2 years and at final follow-up assessment in these patients. In the Grade 2 patients, those pure thoracic radicular pain, Oswestry scores initially improved significantly up to 1 year (P < 0.05). At 2 years, no significant improvement could be shown, and four of the five Grade 2 patients reported increased axial pain as their main symptom at the final follow-up assessment. Significant improvement also was seen in patients with no prior spine surgery and patients with preoperative Oswestry disability scores greater than 50. Of the 68 patients who responded to the final questionnaire, 12 rated the procedure as excellent, 37 as good, 11 as fair, and 8 as poor. Also, 57 (83.8%) of these 68 patients were satisfied and indicated they would recommend the surgery. Of the 36 patients at the final follow up assessment who had severe disability, 34 (94%) were satisfied, as compared with 23 of the 32 patients (72%) who had presented with milder disability., Conclusions: The clinical classification system helps in differentiating different presentations of thoracic disc disease and their final outcome. Video-assisted thorascopic surgery appears to be a safe and efficacious method for the treatment of refractory symptomatic thoracic disc herniations. The current data suggest that the procedure has an acceptable long-term outcome, with an 84% overall subjective patient satisfaction rate, and with objective long-term clinical success achieved in 70% of patients.
- Published
- 2002
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10. Laparoscopic approach to L4-L5 for interbody fusion using BAK cages: experience in the first 58 cases.
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Regan JJ, Aronoff RJ, Ohnmeiss DD, and Sengupta DK
- Subjects
- Adult, Female, Humans, Length of Stay, Lumbar Vertebrae diagnostic imaging, Male, Middle Aged, Postoperative Complications, Spinal Diseases diagnostic imaging, Tomography, X-Ray Computed, Treatment Outcome, Laparoscopy, Lumbar Vertebrae surgery, Spinal Diseases surgery, Spinal Fusion methods
- Abstract
Study Design: Operative reports were reviewed for patients who underwent laparoscopic fusion at the L4-L5 level and information regarding the mobilization of the vessels was recorded., Objective: The purpose of this study was to describe variations in the approach used to address anatomical variations in the location of the great vessel bifurcation in the region of the L4-L5 intervertebral disc space when performing laparoscopic interbody fusion procedures., Summary of Background Data: Recent interest in laparoscopic spine surgery using threaded cages has resulted in questions regarding the ability to safely access the L4-L5 disc using this approach. The laparoscopic transperitoneal approach to L5-S1 is below the bifurcation of the great vessels, thus requiring minimal mobilization of the iliac vessels. However, the transperitoneal approach to L4-L5 may be complicated by the bifurcation of the great vessels anterior to this disc space. Difficulty in placing two cages may occur if the vessels cannot be adequately mobilized., Methods: Data were collected for the consecutive series of the first 58 patients (40 males, 18 females; mean age 42.5 years) undergoing laparoscopic anterior lumbar interbody fusion (ALIF) at the L4-L5 level using BAK cages. Operative notes were reviewed to determine variations in the operative approach. In particular, it was recorded if the L4-L5 disc was accessed above, or below the bifurcation of the aorta and the vena cava, or between these structures. The blood loss, operative time, and length of hospitalization were compared with respect to approach variation., Results: In 30 patients, the L4-L5 disc was accessed above the great vessel bifurcation, in 18 patients below the bifurcation, and in the remaining 10 patients, by passing between the vessels. There were no statistically significant differences in the operative time, blood loss, or length of hospitalization with respect to the approach used. Three patients were converted to open procedures as a result of bleeding from segmental veins. None required transfusions and there were no postoperative sequelae. In two patients, successful endoscopic repair of segmental vein avulsion from the vena cava was performed using endoscopic loop ligatures. One patient had a secondary procedure to remove a cage that was causingnerve irritation, and one patient reported retrograde ejaculation after a two level fusion. Another patient, in whom a posterior herniation was removed, later presented with a cerebrospinal fluid leak. Most of the operative complications occurred early in the series., Conclusions: Laparoscopic transperitoneal approach to L4-L5 for insertion of threaded fusion cages is feasible. The laparoscopic L4-L5 procedure can be accomplished with few complications, provided a dedicated team of collaborative surgeons with experience in laparoscopic spine techniques is employed. Variations in vascular anatomy did not prevent successful insertion of two threaded fusion cages.
- Published
- 1999
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11. Laparoscopic fusion of the lumbar spine: minimally invasive spine surgery. A prospective multicenter study evaluating open and laparoscopic lumbar fusion.
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Regan JJ, Yuan H, and McAfee PC
- Subjects
- Adult, Biocompatible Materials, Feasibility Studies, Female, Follow-Up Studies, Humans, Intervertebral Disc diagnostic imaging, Intervertebral Disc pathology, Length of Stay, Magnetic Resonance Imaging, Male, Postoperative Complications, Prospective Studies, Prosthesis Implantation instrumentation, Safety, Spinal Diseases diagnosis, Titanium, Tomography, X-Ray Computed, Treatment Outcome, Intervertebral Disc surgery, Laparoscopy, Lumbar Vertebrae surgery, Spinal Diseases surgery, Spinal Fusion methods
- Abstract
Study Design: Two hundred-forty consecutive patients underwent laparoscopic instrumented interbody fusion using custom-designed instrumentation and BAK (Sulzer Spine Tech, Minneapolis, MN) fusion cages. The surgeries were performed at eight spine centers during U.S. Food and Drug Administration investigational device evaluation clinical trials. This cohort was compared with 591 consecutive patients undergoing open anterior fusion with the same device., Objectives: To investigate the feasibility and safety of the laparoscopic approach compared with that of open procedures., Summary of Background Data: In other areas of medicine, advances in laparoscopic surgical procedures have resulted in reduced morbidity, expense, and pain when compared with results of the open counterpart., Methods: The open anterior procedure was performed using a retroperitoneal approach. The laparoscopic procedure was performed transperitoneally with carbon dioxide insufflation to provide visualization using a 10-mm endoscope. Two hollow, titanium, threaded interbody implants packed with autologous bone were inserted into the diseased interspace., Results: The laparoscopy group had a shorter hospital stay and reduced blood loss but had increased operative time. Operative time improved in the laparoscopy group as surgeons' experience increased. Operative complications were comparable in both groups, with an occurrence of 4.2% in the open approach and 4.9% in the laparoscopic approach. Overall, the device-related reoperation rate was higher in the laparoscopy group (4.7% vs. 2.3%), primarily as a result of intraoperative disc herniation. Conversion to open procedure in the laparoscopy group was 10%, with most cases predictable and preventable., Conclusions: The laparoscopic procedure is associated with a learning curve, but once mastered, it is effective and safe when compared with open techniques of fusion.
- Published
- 1999
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12. Minimally invasive anterior retroperitoneal approach to the lumbar spine. Emphasis on the lateral BAK.
- Author
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McAfee PC, Regan JJ, Geis WP, and Fedder IL
- Subjects
- Adult, Aged, Endoscopes, Female, Follow-Up Studies, Humans, Joint Instability diagnostic imaging, Length of Stay, Male, Middle Aged, Postoperative Complications, Radiography, Retroperitoneal Space, Spinal Diseases diagnostic imaging, Spinal Diseases surgery, Spinal Fusion instrumentation, Endoscopy methods, Joint Instability surgery, Lumbar Vertebrae surgery, Spinal Fusion methods
- Abstract
Study Design: Eighteen patients with lumbar instability from fractures, postlaminectomy syndrome, or infection were treated prospectively with minimally invasive retroperitoneal lumbar fusions., Objectives: To determine if interbody Bagby and Kuslich fusion cages and femoral allograft bone dowels can be inserted in a transverse direction via a lateral endoscopic retroperitoneal approach to achieve spinal stability., Summary of Background Data: Endoscopic spinal approaches have been used to achieve lower lumbar fusion when instrumentation is placed through a laparoscopic, transperitoneal route. However, complications of using this approach include postoperative intra-abdominal adhesions, retrograde ejaculation, great vessel injury, and implant migration. This study is the first clinical series investigating the use of the lateral retroperitoneal minimally invasive approach for lumbar fusions from L1 to L5., Methods: Eighteen patients underwent anterior interbody decompression and/or stabilization via endoscopic retroperitoneal approaches. In most cases, three 12-mm portals were used. Two parallel transverse interbody cages restored the neuroforaminal height and the desired amount of lumbar lordosis was achieved by inserting a larger anterior cage, distraction plug, or bone dowel., Results: The overall morbidity of the procedure was lower than that associated with traditional "open" retroperitoneal or laparotomy techniques, with a mean length of hospital stay of 2.9 days (range, outpatient procedure to 5 days). The mean estimated intraoperative blood loss was 205 cc (range, 25-1000 cc). There were no cases of implant migration, significant subsidence, or pseudoarthrosis at mean follow-up examination of 24.3 months (range, 12-40 months) after surgery., Conclusions: This preliminary study of 18 patients illustrates that endoscopic techniques can be applied effectively through a retroperitoneal approach with the patient in the lateral position. Unlike the patients who had undergone transperitoneal procedures described in previous reports, in these preliminary 18 patients, there were no cases of retrograde ejaculation, injury to the great vessels, or implant migration.
- Published
- 1998
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13. Video-assisted thoracoscopic excision of herniated thoracic disc: description of technique and preliminary experience in the first 29 cases.
- Author
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Regan JJ, Ben-Yishay A, and Mack MJ
- Subjects
- Adult, Aged, Evaluation Studies as Topic, Follow-Up Studies, Humans, Intraoperative Complications, Magnetic Resonance Imaging, Middle Aged, Postoperative Complications, Radiculopathy diagnosis, Radiculopathy surgery, Surgical Instruments, Thoracic Vertebrae, Treatment Outcome, Endoscopy methods, Intervertebral Disc Displacement surgery, Thoracotomy, Video Recording
- Abstract
This study evaluates the technique and results of video-assisted thoracoscopic surgery (VATS) for the treatment of symptomatic thoracic disc herniation. Results were compared with a literature review of open surgical techniques of thoracic disc excision with regard to efficacy, safety, and surgical outcomes. VATS has recently been described for thoracic surgery as having the advantage of decreased postoperative pain and morbidity, faster patient recovery, and shortened intensive care unit (ICU) hospitalization. Twenty-nine consecutive patients underwent VATS for symptomatic thoracic disc herniation. Herniations ranging from T5-6 to T12-L1 were successfully approached by using a three- or four-portal strategy. Postoperative magnetic resonance imaging (MRI) scans were evaluated. Pre- and postoperative Oswestry Disability Questionnaires and Linear Analog Pain Scale data were obtained. Patients were grouped according to presenting symptoms. The minimal follow-up was 1 year (range, 12-24 months). Mean operative time was 175 min for 29 patients. Significant improvement (p < 0.01, paired t test) was recorded in Oswestry Disability Questionnaires and Linear Analog Scale Tests. Of the patients, 75.8% (22) were satisfied, 3.4% (one) unsatisfied, with 20.1% (six) unchanged. Narcotic use was significantly eliminated or reduced. Mean return to work was 5 weeks (private insurance) and 21 weeks (workers compensation). The surgical and postoperative complication rate was 13.8%. VATS appears to be a safe and efficacious method of excising herniated thoracic discs. Follow-up results at 1 year resulted in high patient satisfaction. VATS advantages include decreased length of hospitalization as well as improved patient comfort.
- Published
- 1998
14. A technical report on video-assisted thoracoscopy in thoracic spinal surgery. Preliminary description.
- Author
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Regan JJ, Mack MJ, and Picetti GD 3rd
- Subjects
- Adult, Diskectomy methods, Female, Humans, Intervertebral Disc Displacement surgery, Length of Stay, Male, Middle Aged, Pain, Postoperative epidemiology, Postoperative Complications epidemiology, Spinal Diseases surgery, Spinal Neoplasms surgery, Television, Thoracic Vertebrae surgery, Thoracoscopy methods
- Abstract
Study Design: This report is a preliminary description of the efficacy of video-assisted thoracoscopic surgery in thoracic spinal procedures that otherwise require open thoracotomy., Objective: This report sought to describe the efficacy of video-assisted thoracoscopic surgery in thoracic spinal procedures that otherwise require open thoracotomy., Summary of Background Data: In a landmark study that compared video-assisted thoracoscopic surgery for peripheral lung lesions with thoracotomy, video-assisted thoracoscopic surgery reduced postoperative pain, improved early shoulder girdle function, and shortened hospital stay., Methods: Video-assisted thoracoscopic surgery was performed in 12 thoracic spinal patients (herniated nucleus pulposus, infection, tumor, or spinal deformity) and is described in detail in this report., Results: Video-assisted thoracoscopic surgery in thoracic spinal surgery resulted in little postoperative pain, short intensive care unit and hospital stays, and little or no morbidity. In the short follow-up period, there was no post-thoracotomy pain syndrome nor neurologic sequelae in these patients. Operative time decreased dramatically as experience was gained with the procedure., Conclusion: Given consistently improving surgical skills, a number of thoracic spinal procedures using video-assisted thoracoscopic surgery, including thoracic discectomy, internal rib thoracoplasty, anterior osteotomy, corpectomy, and fusion, can be performed safely with no additional surgical time or risk to the patient.
- Published
- 1995
15. The effect of sensory deprivation in the reduction of pain in patients with chronic low-back pain.
- Author
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Shea DD, Ohnmeiss DD, Stith WJ, Guyer RD, Rashbaum RF, Hochschuler SH, and Regan JJ
- Subjects
- Adult, Back Pain psychology, Evaluation Studies as Topic, Female, Humans, Male, Pain Measurement, Relaxation Therapy, Back Pain rehabilitation, Palliative Care methods, Sensory Deprivation
- Abstract
Patients who suffer from persistent pain for prolonged periods of time (6 months or more) are often influenced to an increasing extent by psychological factors. Patients begin to focus on their pain as the problem rather than its physical origin. This study evaluated the effectiveness of sensory deprivation in reducing pain in patients with chronic low-back pain. Sixty patients were divided into two groups of 30 patients each: One group underwent 1 hour of sensory deprivation; the other received a lecture on relaxation skills. In the group receiving sensory deprivation, statistically significant decreases in pain and stiffness were noted. Sensory deprivation is an effective treatment to reduce pain and thus interrupt the pain cycle in patients with chronic low-back pain.
- Published
- 1991
- Full Text
- View/download PDF
16. The induction of cardiac arrhythmia and hypotension from spinal cord monitoring. A case report.
- Author
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Regan JJ, McAfee PC, and Achuff SC
- Subjects
- Aged, Evoked Potentials, Somatosensory, Female, Humans, Intraoperative Complications etiology, Hypotension etiology, Monitoring, Physiologic adverse effects, Pacemaker, Artificial, Spinal Cord physiology, Tachycardia etiology
- Published
- 1986
- Full Text
- View/download PDF
17. Personality and response to tricyclic antidepressants in depressed patients.
- Author
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Joffe RT and Regan JJ
- Subjects
- Adult, Antidepressive Agents, Tricyclic administration & dosage, Depressive Disorder complications, Depressive Disorder diagnosis, Drug Evaluation, Female, Humans, Male, Middle Aged, Personality Disorders complications, Personality Inventory, Time Factors, Antidepressive Agents, Tricyclic therapeutic use, Depressive Disorder drug therapy, Personality
- Abstract
Several studies have shown that disturbances of personality are poor predictors of response to antidepressants. None of these studies, however, has used personality measures similar to the DSM-III. We evaluated the relationship between antidepressant response and personality scores obtained on the Millon Clinical Multiaxial Inventory, which provides personality measures congruent with DSM-III. Personality features such as assertiveness, independence, and competitiveness distinguished responders from nonresponders. However, the frequency of personality disorder diagnoses did not differ between responders and nonresponders.
- Published
- 1989
- Full Text
- View/download PDF
18. The biomechanical and histomorphometric properties of anterior lumbar fusions: a canine model.
- Author
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McAfee PC, Regan JJ, Farey ID, Gurr KR, and Warden KE
- Subjects
- Animals, Biomechanical Phenomena, Dogs, Lumbosacral Region, Radiography, Spine diagnostic imaging, Spine pathology, Spinal Fusion, Spine physiopathology
- Abstract
An in vivo model was developed to compare the biomechanical stability, incidence of radiographic union, bone formation rate, and bone graft remodeling parameters of anterior interbody fusions. Eighteen 1-year-old beagles underwent anterior and posterior spinal destabilization procedures at L5-L6 to produce a reproducible amount of spinal instability--resection of the anterior longitudinal ligament, L5-L6 intervertebral disk, L5 and L6 lamina, spinous processes, zygoopophyseal joints, and ligamentum flavum. Group I (N = 6) were surgically destabilized controls; Group II (N = 6) underwent anterior L5-L6 interbody fusion with iliac crest bone graft; and Group III (N = 6) underwent anterior stabilization with a longitudinal fibular strut graft in addition to the same operative procedure as Group II. Six months postoperatively the group with the highest incidence of successful radiographic L5-L6 arthrodesis was Group III, anterior interbody fusion and fibular stabilization (p less than .10). The rank order of biomechanical stability was the same for the three groups for both torsional and axial compressive stiffness, with Group I (destabilized controls) being the least rigid, then Group II (anterior fusion with iliac crest grafting only), and the most rigid to both torsion and axial compressive loading was Group III (anterior fusion with fibular stabilization and iliac crest bone graft). The bone formation rate [mm3/(mm3 x year) x 10(3)], which was derived from the distance between fluorochrome markers, revealed that the more stable the individual spinal construct, the lower the bone formation rate. In summary, the beagle provided a successful model for studying in vivo the response of anterior bone grafts over a 6-month interval and provided comparative biomechanical and histomorphometric data on spinal interbody fusion techniques.
- Published
- 1988
19. Discitis after discography.
- Author
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Guyer RD, Collier R, Stith WJ, Ohnmeiss DD, Hochschuler SH, Rashbaum RF, and Regan JJ
- Subjects
- Adult, Biopsy, Blood Sedimentation, Discitis blood, Discitis diagnosis, Female, Humans, Injections, Spinal, Intervertebral Disc pathology, Magnetic Resonance Imaging, Male, Radiography, Discitis etiology, Intervertebral Disc diagnostic imaging
- Abstract
A series of nine patients with post-discography discitis were evaluated to help delineate the clinical course. The most consistent sign was the marked exacerbation of neck or back pain. This then was followed by an elevated sedimentation rate at an average of 20 days, followed by a positive bone scan at an average of 33 days. Of note is that seven patients initially had negative bone scans at an average of 18 days. Five out of nine patients had changes on plain roentgenograms between 14 and 51 days after discography. Magnetic resonance imaging was performed in six patients; two of these patients were scanned twice. Three scans were negative and five were positive (2 patients initially had negative scans that later became positive). The course of lumbar discitis ranged from 8 to 11 weeks, and cervical discitis from 6 to 7 weeks, with the latter usually resulting in spontaneous fusion.
- Published
- 1988
- Full Text
- View/download PDF
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