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The limb amputation is one of the oldest surgical procedures performed and it still represents an event that drastically changes the life of an individual. Despite the technological progress, the difficulties related to the realization and daily use of the socket remain very common. Among the different technologies adopted in the prosthetic field, this project focused on the osseointegration technique. This technique consists in implanting a stem within the medullary canal of the amputated skeletal segment that extends outside the amputation stump with a prosthesis, later connected to the metal extension. The objective of this PhD project is to treat and to evaluate selected patients with osseointegrated prosthetic implants for the treatment of lower limb amputations. Patients are recruited at the Rizzoli Orthopaedic Institute and at the Prosthesis - INAIL center of Vigorso (Budrio) during outpatient visits, while the surgical procedure is performed by the same expert surgeon in the II Orthopaedic and Traumatology Clinic of the Rizzoli Orthopaedic Institute. The project is still ongoing, to date three patients had completed both procedures, but due to various personal problems, just one of them is included in the analysis. This patient increased his percentage of prosthesis use and the level of mobility with an overall improvement of quality of live after the procedure. The osseointegration technique represents a promising alternative method of treatment for amputees who are not satisfied with their socket prosthesis. In the coming years it will continue the collection of clinical, radiographic and kinematic data of subjects undergoing this procedure in order to perform a long-term monitoring of both clinical outcomes and quality of life.

The purpose of this study was to investigate the clinical results at five years&rsquo, follow-up of a tri-layered nanostructured biomimetic osteochondral scaffold used for focal articular cartilage defects in patients meeting the criteria of early osteoarthritis (EOA). The study population comprised 22 patients (mean age: 39 years), prospectively assessed before surgery, at 24 and 60 months&rsquo, follow-up. Inclusion criteria were: at least two episodes of knee pain for more than 10 days in the last year, Kellgren-Lawrence OA grade 0, I or II and arthroscopic or MRI findings according to the European Society of Sports Traumatology, Knee Surgery &amp, Arthroscopy (ESSKA) criteria. Clinical results demonstrated significant improvement in International Knee Documentation Committee (IKDC) subjective and objective scores and in Tegner score, although activity level never reached the pre-injury level. The complication rate of this study was 8.3%. Two patients underwent re-operation (8.3%), while a comprehensive definition of failure (including both surgical and clinical criteria) identified four failed patients (16.6%) at this mid-term follow-up evaluation. The use of a free-cell osteochondral scaffold represented a safe and valid alternative for the treatment of focal articular cartilage defects in the setting of an EOA, and was able to permit a significant clinical improvement and stable outcome with low complication and failure rates.

PURPOSE: "Early Osteoarthritis (EOA)" has been defined combining clinical, imaging and surgical parameters, with the aim to identify patients in early degenerative phases, who might benefit from the use of available regenerative procedures. Aim of this first clinical trial is to prospectively evaluate the results obtained in a group of patients meeting the inclusion criteria of "EOA" as proposed by the ESSKA Cartilage Committee, and surgically treated with the implantation of a multi-phasic osteochondral scaffold. METHODS: 23 patients were prospectively evaluated at 12 and 24 months of follow-up. Etiology of the chondral or osteochondral defect was rated as microtraumatic or degenerative in 18 cases, and traumatic in 5 cases. Patients included were complaining of clinical symptoms like knee pain and affected by chondral and osteochondral lesions located at the femoral condyles or trochlea and MRI findings demonstrating articular cartilage degeneration and/or meniscal degeneration and/or subchondral bone marrow lesions. RESULTS: All patients increased significantly in any clinical score adopted. The IKDC subjective score increased from 42.8 ± 13.8 at basal evaluation to 74.3 ± 17.4 at 12 months' (p < 0.0005), being stable (74.9 ± 20.4) up to the final follow-up of 24 months. Tegner score showed a statistically significant improvement in sports activity from 3.3 ± 2.7 pre-operative to 4.6 ± 2.2 at 12 months (p < 0.005), with a slight improvement to the final evaluation (4.7 ± 2.1; n.s.). However, the activity level was significantly lower than the pre-injury one (6.1 ± 2.6; p = 0.004). A significant difference was shown between patients younger versus older than 40 years, with younger patients had better clinical improvement (76.0 ± 18.6 vs 45.1 ± 38.8 respectively, p = 0.037). CONCLUSIONS: The implantation of a multi-phasic osteochondral scaffold represents a good option after failure of conservative management for Early OA patients, where younger age represent an important factor for a better outcome. Longer follow-up is needed to evaluate the benefit over time. LEVEL OF EVIDENCE: IV, case series.