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5 result(s) for "Majed, Addie"
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Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial
ObjectivesTo determine the effect of arthroscopic capsular shift surgery on pain and functional impairment for people with atraumatic shoulder (glenohumeral) joint instability.MethodsWe conducted a randomised, placebo-controlled clinical trial in a specialist secondary care facility. Patients aged 18 years and over who reported insecurity (apprehension) in their shoulder joint and had evidence of capsulolabral damage on arthroscopic examination were included. Patients were excluded if their shoulder apprehension symptoms were precipitated by a high velocity shoulder injury, they had bony or neural damage, a rotator cuff or labral tear, or previous surgery on the symptomatic shoulder. Sixty-eight participants were randomised and received diagnostic arthroscopy, followed by arthroscopic capsular shift or diagnostic arthroscopy alone. All participants received the same postoperative clinical care. The primary outcome was pain and functional impairment measured with the Western Ontario Shoulder Instability Index. The prespecified minimum clinically important effect was a reduction in pain and disability of 10.4 points.ResultsMean reductions in pain and functional impairment for both groups were similar. Compared with diagnostic arthroscopy, arthroscopic capsular shift increased pain and functional impairment by means of 5 points (95% CI −6 to 16 points) at 6 months, 1 point (95% CI −11 to 13 points) at 12 months and 2 points (95% CI −12 to 17 points) at 24 months.ConclusionsCompared with diagnostic arthroscopy alone, arthroscopic capsular shift confers, at best, only minimal clinically important benefit in the medium term.Trial registration number NCT01751490.
Elbow conditions: research priorities setting in partnership with the James Lind Alliance
ObjectiveTo undertake a UK-based James Lind Alliance (JLA) Priority Setting Partnership for elbow conditions and be representative of the views of patients, carers and healthcare professionals (HCPs).SettingThis was a national collaborative study organised through the British Elbow and Shoulder Society.ParticipantsAdult patients, carers and HCPs who have managed or experienced elbow conditions, their carers and HCPs in the UK involved in managing of elbow conditions.MethodsThe rigorous JLA priority setting methodology was followed. Electronic and paper scoping surveys were distributed to identify potential research priority questions (RPQs). Initial responses were reviewed and a literature search was performed to cross-check categorised questions. Those questions already sufficiently answered were excluded and the remaining questions were ranked in a second survey according to priority for future elbow conditions research. Using the JLA methodology, responses from HCP and patients were combined to create a list of the top 18 questions. These were further reviewed in a dedicated multistakeholder workshop where the top 10 RPQs were agreed by consensus.ResultsThe process was completed over 24 months. The initial survey resulted in 467 questions from 165 respondents (73% HCPs and 27% patients/carers). These questions were reviewed and combined into 46 summary topics comprising: tendinopathy, distal biceps pathology, arthritis, stiffness, trauma, arthroplasty and cubital tunnel syndrome. The second (interim prioritisation) survey had 250 respondents (72% HCP and 28% patients/carers). The top 18 ranked questions from this survey were taken to the final workshop where a consensus was reached on the top 10 RPQs.ConclusionsThe top 10 RPQs highlight areas of importance that currently lack sufficient evidence to guide diagnosis, treatment and rehabilitation of elbow conditions. This collaborative process will guide researchers and funders regarding the topics that should receive most future attention and benefit patients and HCPs.
2 Arthroscopic capsular shift surgery in patients with atraumatic shoulder instability: a randomised placebo-controlled trial
IntroductionAtraumatic shoulder instability (ASI) occurs in the absence of significant trauma and can impair shoulder function. Arthroscopic capsular shift (ACS) is recommended in persistent symptoms. The primary objective of this trial was to determine the effect of ACS in ASI.Materials and MethodsA single-centre, two-arm, randomized, placebo-controlled clinical trial incorporating concealed intervention assignment, blinded assessment, and analysis by intention-to-treat was conducted. Patients over 18 years, with positive apprehension tests and evidence of capsulo-labral damage on arthroscopy, were eligible for inclusion. Participants were randomised to ACS or arthroscopy only. All patients received the same post-operative care.The primary outcome was the Western Ontario Shoulder Instability Index (WOSI), a change of 10.4 points was considered to be clinically significant. Secondary outcomes included global perceived change and episodes of dislocations. Patients were followed up at 6, 12 and 24 months.Results68 patients, average age 25.6 (SD 6.4), 53 females (77.9%) were randomised into the trial. Complete primary outcome data were available for 61 (90%), 59 (87%) and 56 (82%) at 6, 12 and 24 months respectively.Mean change on the WOSI scores at 6, 12 and 24 months were 5, 1 and 2 points respectively. Confidence intervals were narrow enough to rule out a clinically worthwhile beneficial effect of ACS at 6 months and the confidence intervals were nearly narrow enough to rule out clinically worthwhile effects at 12 and 24 months.ConclusionThe data suggest that ACS has no additional benefit in management of ASI compared to placebo.
Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial
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
Acutely calcified hematoma mimicking a displaced medial epicondyle fracture
We present an interesting and unusual case of an acutely calcified pin-site infection hematoma mimicking a displaced cartilaginous medial epicondyle, in a child with a Gartland type III fracture. The treatment of such pathology could be confusing and may interfere with the correct clinical decision-making process. To our knowledge, this is the first presentation of such a case.