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New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Intra-medullary tumour length is accurately assessed on T1-weighted turbo spin echo (T1W TSE) MRI which can be relatively time consuming, whilst the gradient echo Dixon (T1W GrE Dixon) technique is a rapid sequence (imaging time ~ 30 s). The aim of this study was to determine if the out-of-phase Dixon (OP T1W GrE Dixon) sequence can produce equivalent measurements of intra-medullary tumour length compared to the T1W TSE sequence. Tumour length was assessed in 90 patients undergoing MRI for staging of primary bone tumours with both T1W TSE and OP T1W GrE Dixon MRI sequences at 3 T (n = 42) and 1.5 T (n = 48). Tumour length was measured independently by different observers allowing assessment of inter-observer correlation, and the correlation between measurements on T1W TSE and OP T1W GrE Dixon sequences was also determined. There were 53 males and 37 females (mean age 36.4 years; range 2–77 years). Inter-observer correlation for tumour length on both the T1W TSE and T1W OP GrE Dixon sequences was very good (ICC = 0.94–0.98), and measurement of tumour length comparing T1W TSE and T1W GrE Dixon was also very good (ICC = 0.91–0.99). In 4 cases, tumour length was significantly overestimated on T1W TSE images due to extensive reactive marrow oedema, but more accurately determined on the OP sequence when compared to resection specimens. The OP T1W GrE Dixon sequence is comparable to T1W TSE for assessment of the intra-medullary length of appendicular bone tumours, and more accurate in the presence of extensive reactive marrow oedema.

Objective: To determine its ability of in-phase (IP) and out-of-phase (OOP) chemical shift imaging (CSI) to distinguish non-neoplastic marrow lesions, benign bone tumours and malignant bone tumours. Methods: CSI was introduced into our musculoskeletal tumour protocol in May 2018 to aid in characterisation of suspected bone tumours. The % signal intensity (SI) drop between IP and OOP sequences was calculated and compared to the final lesion diagnosis, which was classified as non-neoplastic (NN), benign neoplastic (BN) or malignant neoplastic (MN). Results: The study included 174 patients (84 males; 90 females: mean age 44.2 years, range 2–87 years). Based on either imaging features (n = 105) or histology (n = 69), 44 lesions (25.3%) were classified as NN, 66 (37.9%) as BN and 64 (36.8%) as MN. Mean % SI drop on OOP for NN lesions was 36.6%, for BN 3.19% and for MN 3.24% (p < 0.001). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy of CSI for differentiating NN from neoplastic lesions were 65.9%, 94.6%, 80.6%, 89.1%% and 87.4% respectively, and for differentiating BN from MN were 9.1%, 98.4%, 85.7%, 51.2 and 53.1% respectively. Conclusion: CSI is accurate for differentiating non-neoplastic and neoplastic marrow lesions, but is of no value in differentiating malignant bone tumours from non-fat containing benign bone tumours. Advances in knowledge: CSI is of value for differentiating non-neoplastic marrow lesions from neoplastic lesions, but not for differentiating benign bone tumours from malignant bone tumours as has been previously reported.

The objective of this study is to compare T1-weighted gradient echo (T1W GrE: control technique) chemical shift imaging (CSI) with T2-weighted fast spin echo (T2W FSE: experimental technique) CSI for differentiating non-neoplastic and neoplastic marrow lesions. Patients undergoing MRI for various marrow lesions were investigated with T1W GrE and T2W FSE Dixon CSI. Signal intensity (SI) change between in-phase (IP) and opposed-phase (OP) sequences was calculated, and SI drop > 20% considered to represent non-neoplastic lesions while SI drop

In-phase (IP) and out-of-phase (OOP) chemical shift imaging (CSI) is an established technique for clarifying the nature of indeterminate bone marrow lesions, a signal intensity (SI) drop of > 20% at 1.5 tesla (T) or > 25% on 3 T on the OOP sequence being consistent with a non-neoplastic process. Occasionally, SI increase is seen on OOP sequences. The aim of this study is to determine if this is related to marrow sclerosis or matrix mineralisation. In 184 cases, the SI change on OOP was calculated. For patients in whom the SI on OOP increased compared with the IP sequence, available CT studies and radiographs were reviewed to look for marrow sclerosis and/or matrix mineralisation. Forty out of 184 patients (34.25%) showed an anomalous increase in SI on the OOP sequence. CT studies were available in 27 cases (67.5%), of which medullary sclerosis was seen in 20 (74.1%) while matrix mineralisation was seen in a further 2 cases. Review of radiographs demonstrated matrix mineralisation in 6 cases, while punctate signal void consistent with chondral calcification was seen on MRI in 2 more cases. Based on either typical imaging features (n = 22) or histology (n = 18), 7 lesions (17.5%) were classed as non-neoplastic, 18 (45%) as benign neoplasms and 15 (37.5%) as malignant neoplasms. When assessing focal marrow lesions with CSI, anomalous SI increase may be seen on the OOP sequence in approximately one-third of cases. In over 75% of such cases, CT or radiographs demonstrate either diffuse marrow sclerosis or matrix mineralisation.

Dixon sequences are established as a reliable MRI technique that can be used for problem-solving in the assessment of bone marrow lesions. Unlike other fat suppression methods, Dixon techniques rely on the difference in resonance frequency between fat and water and in a single acquisition, fat only, water only, in-phase and out-of-phase images are acquired. This gives Dixon techniques the unique ability to quantify the amount of fat within a bone lesion, allowing discrimination between marrow-infiltrating and non-marrow-infiltrating lesions such as focal nodular marrow hyperplasia. Dixon can be used with gradient echo and spin echo techniques, both two-dimensional and three-dimensional imaging. Another advantage is its rapid acquisition time, especially when using traditional two-point Dixon gradient echo sequences. Overall, Dixon is a robust fat suppression method that can also be used with intravenous contrast agents. After reviewing the available literature, we would like to advocate the implementation of additional Dixon sequences as a problem-solving tool during the assessment of bone marrow pathology.

Objectives: To compare the grading of lumbar degenerative disc disease (DDD), Modic end-plate changes (MEPC) and identification of high intensity zones (HIZ) on a combination of sagittal T1weighted turbo spin echo (T1W TSE), T2weighted fast spin echo (T2W FSE) and short tau inversion recovery (STIR) sequences (routine protocol) with a single sagittal T2W FSE Dixon MRI sequence which provides in-phase, opposed-phase, water only and fat only images in a single acquisition (Dixon protocol). Methods: 50 patients underwent lumbar spine MRI using the routine protocol with the addition of a T2W FSE Dixon sequence. DDD grade, MEPC and HIZ for each disc level were assessed on the routine and Dixon protocols. Each protocol was reviewed independently by three readers (consultant musculoskeletal radiologists with 26-, 8- and 4 years’ experience), allowing assessment of inter-reader agreement and inter protocol agreement for each assessed variable. Results: The study included 17 males and 33 females (mean age 51 years; range 8–82 years). Inter-reader agreement for DDD grade on the routine protocol was 0.57 and for the Dixon protocol was 0.63 (p = 0.08). Inter-reader agreement for MEPC on the routine protocol was 0.45 and for the Dixon protocol was 0.53 (p = 0.02), and inter-reader agreement for identification of the HIZ on the routine protocol was 0.52 and for the Dixon protocol was 0.46 (p = 0.27). Intersequence agreement for DDD grade ranged from 0.61 to 0.97, for MEPC 0.46–0.62 and for HIZ 0.39–0.5. Conclusion: A single sagittal T2W FSE Dixon MRI sequence could potentially replace the routine three sagittal sequence protocol for assessment of lumbar DDD, MEPC and HIZ resulting in ~60% time saving. Advances in knowledge: Grading of lumbar DDD, presence of Modic changes and high intensity zones were compared on sagittal T1W TSE, T2W FSE and STIR sequences with a T2W FSE Dixon sequence, with fair-to-good correlation suggesting that three conventional sequences could be replaced by a single Dixon sequence.