23 research outputs found

    Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP Lesions of the shoulder: a randomised controlled trial

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    <p>Abstract</p> <p>Background</p> <p>Surgery for type II SLAP (superior labral anterior posterior) lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months) and long-term (2 years) efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy) for alleviating pain and improving function for type II SLAP lesions.</p> <p>Methods/Design</p> <p>A double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version) and the Western Ontario Instability Index (WOSI) at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ), the generic EuroQol (EQ-5 D and EQ-VAS), return to work and previous sports activity, complications, and the number of reoperations.</p> <p>Discussion</p> <p>The results of this trial will be of international importance and the results will be translatable into clinical practice.</p> <p>Trial Registration</p> <p><b>[ClinicalTrials.gov NCT00586742]</b></p

    Responsiveness of five shoulder outcome measures at follow-ups from 3 to 24 months

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    Background To assess responsiveness of five outcome measures at four different follow-ups in patients with SLAP II lesions of the shoulder. Methods 119 patients with symptoms and signs, MRI arthrography and arthroscopic findings were included. The Western Ontario Shoulder Instability Index (WOSI), Oxford Instability Shoulder Score (OISS), EuroQol (EQ-5D3L), Rowe Score and Constant-Murley Score (CMS) were assessed at baseline, 3, 6, 12 and 24 months. The analysis contains both anchor-based and distribution-based methods, and hypothesis testing. Results Confidence intervals for ROC cut-off values, representing MID, for OISS, CMS and EQ-5D3L crossed zero at 3 months. Cut-off values were stable between 6- and 24-months follow-up. At 24-months ROC cut-off values (95% CI) were: Rowe 18 (13 to 24); WOSI 331 (289 to 442); OISS 9 (5 to 14); CMS 11 (9 to 15) and EQ-5D3L 0.123 (0.035 to 0.222). MID95%limit estimates were substantially higher than ROC cut-off values and MIDMEAN at all follow-ups for all instruments. The reliable change proportion (RCP) values in the improved group were highest for WOSI and the Rowe Score (ranging from 68 to 87%) and significantly lower for CMS. EQ-5D3L had the lowest values (13 to 16%). We found a moderate correlation between mean change scores of the outcome measures and the anchor, except for the EQ-5D3L. Conclusions In patients with SLAP II-lesions the patient reported OISS and WOSI and the clinical Rowe score had best responsiveness. Our results suggest that 3 months follow-up is too early for outcome evaluation

    Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial

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    Background: Labral repair and biceps tenodesis are routine operations for superior labrum anterior posterior (SLAP) lesion of the shoulder, but evidence of their efficacy is lacking. We evaluated the effect of labral repair, biceps tenodesis and sham surgery on SLAP lesions. Methods: A double-blind, sham-controlled trial was conducted with 118 surgical candidates (mean age 40 years), with patient history, clinical symptoms and MRI arthrography indicating an isolated type II SLAP lesion. Patients were randomly assigned to either labral repair (n=40), biceps tenodesis (n=39) or sham surgery (n=39) if arthroscopy revealed an isolated SLAP II lesion. Primary outcomes at 6 and 24 months were clinical Rowe score ranging from 0 to 100 (best possible) and Western Ontario Shoulder Instability Index (WOSI) ranging from 0 (best possible) to 2100. Secondary outcomes were Oxford Instability Shoulder Score, change in main symptoms, EuroQol (EQ-5D and EQ-VAS), patient satisfaction and complications. Results: There were no significant between-group differences at any follow-up in any outcome. Between-group differences in Rowe scores at 2 years were: biceps tenodesis versus labral repair: 1.0 (95% CI −5.4 to 7.4), p=0.76; biceps tenodesis versus sham surgery: 1.6 (95% CI −5.0 to 8.1), p=0.64; and labral repair versus sham surgery: 0.6 (95% CI −5.9 to 7.0), p=0.86. Similar results—no differences between groups—were found for WOSI scores. Postoperative stiffness occurred in five patients after labral repair and in four patients after tenodesis. Conclusion: Neither labral repair nor biceps tenodesis had any significant clinical benefit over sham surgery for patients with SLAP II lesions in the population studied

    Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomized sham-controlled study.

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    Objectives To compare days on sick leave and assess predictors of return to work following shoulder surgery. Design A secondary analysis of a randomised controlled trial. Setting Orthopaedic department. Participants 114 patients with type II superior labral tear from anterior to posterior of the shoulder. Interventions Labral repair, biceps tenodesis or sham surgery. Outcome measures Sick leave was obtained from national registers for the last year before and 2 years following surgery. Total and shoulder related number of days on sick leave were obtained, using international diagnostic codes. We applied the difference-in-difference approach to compare the differences in the change in mean work days on sick leave between groups over time, backwards logistic regression and lasso regression to evaluate predictors. Results Mean total number of work days on sick leave during the 2 years after surgery was 148 (range 0–460) days. More than 80% of the sick leave days were taken by 22% of the patients. Days on sick leave classified as shoulder-related constituted 80% of the total. In all three treatment groups, the mean total number of days on sick leave doubled the year after surgery. Sham surgery and labral repair had fewer postoperative sickness absence days compared with biceps tenodesis but differences were not significant when adjusted for days of sick leave the year before surgery. Predictors of return to work at 2 years analysed by logistic regression were no sick leave (OR 8.0, 95% CI 2.4 to 26.0) and moderate symptoms of anxiety or depression (OR 0.16, 95% CI 0.05 to 0.5) at inclusion. Similar results were obtained by lasso regression but manual work was an additional predictor. Conclusions Change in mean work days on sick leave comparing sham surgery, labral repair and biceps tenodesis, was not significantly different. Sick leave, symptoms of anxiety and depression, and manual work at inclusion predicted work status 2 years after surgery

    Analysis of Parent-of-Origin Effects on the X Chromosome in Asian and European Orofacial Cleft Triads Identifies Associations with DMD, FGF13, EGFL6, and Additional Loci at Xp22.2

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    Background: Although both the mother's and father's alleles are present in the offspring, they may not operate at the same level. These parent-of-origin (PoO) effects have not yet been explored on the X chromosome, which motivated us to develop new methods for detecting such effects. Orofacial clefts (OFCs) exhibit sex-specific differences in prevalence and are examples of traits where a search for various types of effects on the X chromosome might be relevant. Materials and Methods: We upgraded our R-package Haplin to enable genome-wide analyses of PoO effects, as well as power simulations for different statistical models. 14,486 X-chromosome SNPs in 1,291 Asian and 1,118 European case-parent triads of isolated OFCs were available from a previous GWAS. For each ethnicity, cleft lip with or without cleft palate (CL/P) and cleft palate only (CPO) were analyzed separately using two X-inactivation models and a sliding-window approach to haplotype analysis. In addition, we performed analyses restricted to female offspring. Results: Associations were identified in “Dystrophin” (DMD, Xp21.2-p21.1), “Fibroblast growth factor 13” (FGF13, Xq26.3-q27.1) and “EGF-like domain multiple 6” (EGFL6, Xp22.2), with biologically plausible links to OFCs. Unlike EGFL6, the other associations on chromosomal region Xp22.2 had no apparent connections to OFCs. However, the Xp22.2 region itself is of potential interest because it contains genes for clefting syndromes [for example, “Oral-facial-digital syndrome 1” (OFD1) and “Midline 1” (MID1)]. Overall, the identified associations were highly specific for ethnicity, cleft subtype and X-inactivation model, except for DMD in which associations were identified in both CPO and CL/P, in the model with X-inactivation and in Europeans only. Discussion/Conclusion: The specificity of the associations for ethnicity, cleft subtype and X-inactivation model underscores the utility of conducting subanalyses, despite the ensuing need to adjust for additional multiple testing. Further investigations are needed to confirm the associations with DMD, EGF16, and FGF13. Furthermore, chromosomal region Xp22.2 appears to be a hotspot for genes implicated in clefting syndromes and thus constitutes an exciting direction to pursue in future OFCs research. More generally, the new methods presented here are readily adaptable to the study of X-linked PoO effects in other outcomes that use a family-based design

    Factors correlated with pain after total knee arthroplasty: A systematic review and meta-analysis.

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    Main objectiveSystematically review and synthesize preoperative and intraoperative factors associated with pain after total knee arthroplasty (TKA) in patients with osteoarthritis.MethodsBased on a peer-reviewed protocol, we searched Medline, Embase, CINAHL, Cochrane Library, and PEDro for prospective observational studies (January 2000 to February 2023) investigating factors associated with pain after TKA. The primary outcome was pain twelve months after TKA. Pain at three and six months were secondary outcomes. Multivariate random-effects meta-analyses were used to estimate mean correlation (95% CIs) between factors and pain. Sensitivity analysis was performed for each risk of bias domain and certainty of evidence was assessed.ResultsOf 13,640 studies, 29 reports of 10,360 patients and 61 factors were analysed. The mean correlation between preoperative factors and more severe pain at twelve months was estimated to be 0.36 (95% CI, 0.24, 0.47; P Conclusion and relevanceMore pain catastrophizing, more symptomatic joints and more pain preoperatively were correlated with more pain, while more severe osteoarthritis was correlated with less pain one year after TKA. More preoperative pain was correlated with more pain, and better mental health with less pain at six and three months. These findings should be further tested in predictive models to gain knowledge which may improve TKA outcomes

    An illustration of the HAPLIN model for the X-chromosome.

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    <p>The red arrows show the relative risks (RR) associated with girls inheriting a double dose of the risk allele “a”, RRG2. Under the multiplicative risk model illustrated here, RRG2 = RRG1·RRG1, where RRG1 is the relative risk associated with girls inheriting a single dose of “a”. Under the assumption of X-inactivation (<b>Panel A</b>), the risk increase for girls inheriting a double dose of “a” is no larger than the increase for boys (RRB) inheriting the “a” allele, i.e. RRG2 = RRB. Under the assumption of no X-inactivation (<b>Panel B</b>), the risk increase for girls inheriting a single dose of “a” is the same as the increase for boys when inheriting the “a”, i.e. RRG1 = RRB, whereas the increase for girls inheriting a double dose is larger. The model allows different baseline prevalences for girls versus boys, here 40 versus 50 per 10 000, respectively.</p
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