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

Onze Lieve Vrouwe Gasthuis

Status: Completed

Conditions: Rotator Cuff Syndrome

Treatments: Procedure: Arthroscopic rotator cuff repair; Procedure: LHB Tenotomy; Procedure: LHB Tenodesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02655848

WO 10.087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients older than 50 years
• Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter.
• Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.

Exclusion criteria

• Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
• Accompanying subscapularis tendon lesion
• Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture.
• Osteoarthritis of the glenohumeral joint
• Acromion to humeral head distance measuring 6mm or smaller.
• Prior surgery to the involved shoulder
• Dementia or inability to complete questionnaires and assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

@ Cuff repair with LHB tenodesis

Active Comparator group

Description:

In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.

Treatment:

Procedure: LHB Tenodesis

Procedure: Arthroscopic rotator cuff repair

@ cuff repair with LHB tenotomy

Active Comparator group

Description:

In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.

Treatment:

Procedure: Arthroscopic rotator cuff repair

Procedure: LHB Tenotomy