NCT02655848

Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair

Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Onze Lieve Vrouwe Gasthuis · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Rotator Cuff Syndrome

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic rotator cuff repair	Arthroscopic rotator cuff repair using suture anchors
PROCEDURE	LHB Tenodesis	Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
PROCEDURE	LHB Tenotomy	Arthroscopic tenotomy of long head biceps

Timeline

• Start date: 2012-07-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-01-14
• Last updated: 2019-10-01

Locations

10 sites across 1 country: Netherlands