Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).

INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials. METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media. TRIAL REGISTRATION NUMBER: ISRCTN17825590.

Microvascular blood flow in normal and pathologic rotator cuffs.

BACKGROUND: Microvascular blood flow in the tendon plays an important role in the pathogenesis of rotator cuff abnormalities. There are conflicting views about the presence of a hypovascular zone in the supraspinatus tendon. Besides, no studies have looked at the pattern of blood flow around a partial-thickness tear. Our aim was to measure microvascular blood flow in normal and a range of pathologic rotator cuff tendons using laser doppler flowmetry. METHODS: A total of 120 patients having arthroscopic shoulder surgery were divided into 4 equal groups on the basis of their intraoperative diagnosis: normal rotator cuff, subacromial impingement syndrome, and partial-thickness or full-thickness rotator cuff tear. Microvascular blood flow was measured at 5 different regions of each cuff using a laser doppler probe. The values were compared to assess variability within and between individuals. RESULTS: Total blood flow was greater in the normal rotator cuff group compared with the groups with pathologic rotator cuffs, with the largest difference seen in the subacromial impingement group. Within individuals, blood flow was highest at the musculotendinous junction and lowest at the lateral insertional part of the tendon. Among groups, the blood flow was significantly lower at the anteromedial and posteromedial cuff in the groups with impingement and full-thickness tears compared with the group with normal cuff. CONCLUSION: Real-time in vivo laser doppler analysis has shown that microvascular blood flow is not uniform throughout the supraspinatus tendon. Blood flow in the pathologic supraspinatus tendon was significantly lower compared with the normal tendon.

Mid-term results of Copeland shoulder cementless surface replacement arthroplasty from an independent centre.

BACKGROUND: The present study reports our experience of Copeland shoulder cementless surface replacement arthroplasty (CSRA) and whether glenoid microfracture influences the progression of glenoid erosion. METHODS: One-hundred-and-twelve CSRAs were performed in 101 patients between 2002 and 2007. Eighty-three patients were alive at the median follow-up time of 72 months (range 9 to 121 months; interquartile range 46 to 93 months). Assessment included an Oxford shoulder score (OSS), patient satisfaction score and plain radiographs. RESULTS: The mean (range) OSS was 27 (7 to 48) and 64 of 73 (87.7%) patients were 'very satisfied' or 'satisfied' with their shoulder. Twenty-three (20.5%) shoulders had over 2 mm of glenoid erosion. Microfracture was performed in 43 of 112 shoulders (38.4%) and did not influence the progression of glenoid erosion. Further surgery was performed in 27 (24.1%) shoulders, including 15 revisions, eight arthrolyses and four subacromial decompressions. Revision to total shoulder arthroplasty was performed in 14 : 10 for glenoid erosion; one each for loosening, periprosthetic fracture, deep infection, and chronic pain. One was revised to reverse arthroplasty for chronic pain. CONCLUSIONS: CSRA performed in an independent centre reproduces the functional outcomes reported by the designer. Glenoid erosion, however, was a common occurrence and the main cause of revision - microfracture did not influence its progression.

Accuracy of abduction-external rotation MRA versus standard MRA in the diagnosis of intra-articular shoulder pathology.

The goal of this study was to compare the accuracy of abduction-external rotation magnetic resonance arthrography (ABERMRA) with standard MRA in the diagnosis of intra-articular shoulder pathology.One hundred three consecutive patients undergoing preoperative direct MRA and subsequent arthroscopic examination were included in the study. Seventy-eight patients underwent standard MRA and 25 underwent ABERMRA. Specialist-trained musculoskeletal radiologists reported all scans, and attending shoulder surgeons performed all arthroscopies. Arthroscopic assessment revealed 11 partial-thickness rotator cuff tears, 3 full-thickness tears, 64 labral lesions (48 soft tissue and 16 significant bony), and 17 superior labrum anterior-posterior (SLAP) tears. The sensitivity/specificity for standard MRA was 0.56/0.99 for partial-thickness rotator cuff tears, 1.00/1.00 for full-thickness rotator cuff tears, 0.75/0.91 for soft tissue labral tears, 0.58/1.00 for significant bony glenoid lesions, and 0.50/0.91 for SLAP tears. Abduction-external rotation magnetic resonance arthrography increased the sensitivity/specificity to 1.00/0.85 for soft tissue labral tears, 0.75/1.00 for significant bony glenoid lesions, and 1.00/1.00 for SLAP tears, although it missed 2 of 2 partial-thickness rotator cuff tears.This study suggests that standard MRA is a valuable investigation tool for instability, SLAP tears, and rotator cuff tears, although limitations exist. Additional ABERMRA sequences appear to improve the diagnostic accuracy of soft tissue anterior and posterior labral tears, SLAP tears, and significant bony glenoid lesions and should be routinely requested by shoulder surgeons when ordering MRAs to obtain the maximum benefit from this invasive investigation.

Partial-thickness articular surface rotator cuff tears in patients over the age of 35: Etiology and intra-articular associations.

PURPOSE: Partial-thickness articular-sided rotator cuff tears have a multifactorial etiology and are associated with degeneration of the tendon. They are often described as an injury of the young athlete, although they are also found in the older population. The aim of this study was to investigate the frequency and associations of partial-thickness articular-sided tears in patients over the age of 35 years. DESIGN: Retrospective MATERIALS AND METHODS: A retrospective study of all arthroscopic procedures for rotator cuff pathology in patients over the age of 35 years over a 2-year period by a single surgeon was performed. The included patients were divided into two groups based on the arthroscopic findings: those with a partial-thickness articular-sided rotator cuff tear and those with pure tendinopathy. The groups were then compared to identify the associated pathology with the rotator cuff lesions. 2×2 contingency table analysis and unpaired Student's t-test were used for statistical analysis. RESULTS: One hundred patients were included in the study of whom 62 had a partial articular-sided tear. Those with a partial articular-sided tear were older (P=0.0001), were more commonly associated with a documented injury (P=0.03), and more commonly had biceps degeneration (P=0.001) and synovitis (P=0.02) within the joint. CONCLUSION: Partial-thickness articular-sided tears are a common occurrence in patients requiring arthroscopic surgery for rotator cuff pathology over the age of 35 years. This probably reflects an injury in an already degenerate cuff. This would support the theory of intrinsic degeneration of the tendon in this age group and probably represent a different etiology to those seen in the young athletes. LEVEL OF EVIDENCE: Level 3.

Focal liver lesion detection and characterization with diffusion-weighted MR imaging: comparison with standard breath-hold T2-weighted imaging.

PURPOSE: To retrospectively compare diffusion-weighted (DW) magnetic resonance (MR) imaging with standard breath-hold T2-weighted MR imaging for focal liver lesion (FLL) detection and characterization, by using consensus evaluation and other findings as the reference standard. MATERIALS AND METHODS: Approval for this retrospective HIPAA-compliant study was obtained from the institutional review board; informed consent was waived. Fifty-three consecutive patients (30 men, 23 women; mean age, 60.7 years) with at least one FLL of 1 cm or greater in diameter were evaluated. Two independent observers reviewed DW (b values of 0, 50, and 500 sec/mm(2)) and T2-weighted images for FLL detection and characterization. Reference standard for diagnosis was obtained from consensus review by the two observers of DW, T2-weighted, and dynamic contrast material-enhanced images, pathologic data, and follow-up imaging results. Apparent diffusion coefficient (ADC) was measured for FLLs identified at consensus review. DW and T2-weighted images were compared for FLL detection and characterization by using a binary logistic regression model. Receiver operating characteristic curve analyses were conducted to evaluate the utility of ADC for diagnosis of malignancy. RESULTS: Two hundred eleven FLLs (136 malignant, 75 benign) were detected at consensus review. Overall detection rate (averaged for two observers) was significantly higher for DW (87.7%) versus T2-weighted (70.1%) imaging (P < .001). FLL characterization was not significantly different between DW (89.1%) and T2-weighted (86.8%) imaging (P = .51). ADCs of malignant FLLs were significantly lower than those of benign FLLs (P < .001). The area under the curve for diagnosis of malignancy was 0.839, with sensitivity of 74.2%, specificity of 77.3%, positive predictive value of 85.5%, negative predictive value of 62.3%, and accuracy of 75.3%, by using a threshold ADC of less than 1.60 x 10(-3) mm(2)/sec. CONCLUSION: DW MR imaging was better than standard breath-hold T2-weighted imaging for FLL detection and was equal to breath-hold T2-weighted imaging for FLL characterization.