Rotator Cuff Syndrome Clinical Trial
Official title:
Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. The hypothesis is that there is no difference in functional outcome between LHB tenotomy and LHB 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 3cm, who are encountered with LHB pathology, will be randomized to either LHB
tenotomy or LHB tenodesis. Clinical and self-reported data will be collected pre-operatively,
and 6 weeks, 3 months, and 1 year after surgery.
Primary outcome is overall shoulder function evaluated with the Constant score. As additional
measures of shoulder function, 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, arm cramping pain, elbow flexion strength,
MRI evaluation, quality of life, and cost of surgery. To detect non-inferiority with a
one-sided, two-sample t-test with a 80% power and a significance level (alpha) of 0.025, the
required sample size is 98 patients.
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