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Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol.

ABSTRACT: Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodological quality, and only two were randomized controlled trials (RCTs). As strong evidence in favor of either tenotomy or tenodesis is still lacking, we designed this randomized controlled trial to compare functional outcomes after tenotomy and tenodesis when performed in adjunct to arthroscopic rotator cuff repair.Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3 cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and patient-reported data will be collected pre-operatively, 6 weeks, 3 months and 1 year after surgery. Primary outcome is overall shoulder function evaluated with the Constant score at 1 year after surgery. As additional measures of shoulder function, two patient reported outcomes (the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire) will be assessed. Other evaluations include cosmetic appearance evaluated by the "Popeye" deformity, elbow flexion strength, arm cramping pain, MRI-based location of the biceps tendon, quality of life, and duration of surgery. To detect non-inferiority with a one-sided, two-sample t-test with 80 % power and a significance level (alpha) of 0.025, the required sample size is 98 patients.Treatment of LHB tendon lesions is performed differently around the world and meta analyses do not provide conclusive evidence in favor of one of these treatments. This study will strengthen evidence on the risks and benefits of LHB tenotomy and tenodesis in adjunct to a rotator cuff repair, which is important for managing patient expectations.Dutch Trial Register ( NTR3255 ) January 12, 2012, ClinicalTrials.gov (ID NCT02655848 ) January 14, 2016, retrospectively registered.

SUBMITTER: van Deurzen DF

PROVIDER: S-EPMC5004307 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol.

van Deurzen Derek Friedrich Petrus DF Scholtes Vanessa Antoinet Bernice VA Willigenburg Nienke Willemien NW Gurnani Navin N Verweij Lukas Pieter Eduard LP van den Bekerom Michel Pieter Jozef MP

BMC musculoskeletal disorders 20160830 1

<h4>Background</h4>Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodological quality, and only two were randomized controlled trials (RCTs). As strong evidence in favor of either tenotomy or tenodesis is still lacking, we designed this randomized controlled trial ...[more]

PMID: 27577549

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Project description:ContextA comparison of clinical outcomes after long head of biceps (LHB) tenotomy or tenodesis performed concurrently with rotator cuff repair (RCR) is of interest to physicians and patients.ObjectiveA systematic review of clinical outcome studies examining LHB tenotomy or tenodesis performed concurrently with RCR. Secondarily, perform a meta-analysis of data from comparative studies.Data sourcesMEDLINE (1946 to week 30 of 2013) and EMBASE (1980 to week 30 of 2013).Study selectionLevels 1 through 4 studies reporting clinical outcomes of concurrent RCR and LHB tenotomy or tenodesis with minimum 1-year follow-up.Study designSystematic review and meta-analysis.Level of evidenceLevel 4.Data extractionTwo independent reviewers identified eligible studies and applied the exclusion criteria. Clinical outcome data, including functional outcome score(s), biceps deformity and cramping, and patient satisfaction, were extracted. Clinical outcome data from included studies were pooled (weighted according to study size) and reported. A meta-analysis was performed only on outcomes extracted from comparative studies (? = 0.05).ResultsTwelve studies (N = 565 patients; mean age, 61.3 years; 46.3% men) were included. Of these, 6 (N = 263) included RCR and LHB tenotomy and 9 (N = 302) included RCR and LHB tenodesis. A meta-analysis was performed on 3 comparative studies (levels 1 and 2), demonstrating that the postoperative Constant score at a mean follow-up of 25.5 months was significantly greater after tenodesis (92.8 [tenodesis] vs 90.6 [tenotomy], P < 0.01); however, this difference was less than the reported minimal clinically important difference of 10.4 points. Similarly, the rate of biceps deformity was significantly less after tenodesis (15.5% [tenotomy] vs 3.9% [tenodesis], P < 0.01); however, most patients were not bothered by it. There were no significant differences in the rate of biceps cramping or patient satisfaction.ConclusionAlthough the postoperative Constant score and rate of biceps deformity favor LHB tenodesis statistically, the clinical significance appears negligible.

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Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol.

Publications

Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol.

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