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

Onze Lieve Vrouwe Gasthuis98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rotator Cuff Syndrome

Interventions

Arthroscopic rotator cuff repairPROCEDURE

Arthroscopic rotator cuff repair using suture anchors

LHB TenodesisPROCEDURE

Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove

LHB TenotomyPROCEDURE

Arthroscopic tenotomy of long head biceps

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Slootervaart ziekenhuis

Amsterdam, Netherlands

Kliniek De Lairesse

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Gelre ziekenhuis

Apeldoorn, Netherlands

Outcomes

Primary Outcomes

Shoulder function quantified with the Constant score (0-100)

Sum of the items below: ADL: Patient reported shoulder function during work (0-4), recreation/sports (0-4), and sleep (0-2). Pain: Patient reported pain in the shoulder (severe=0,moderate=5,mild=10,no pain=15). ROM: Anteflexion up to waist(2)/xiphoid process(4)/neck(6)/head(8)/above head(10) Elevation in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) Abduction in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) External rotation: impossible to reach head with hand(0)/hand behind head-elbow forward(2)/hand behind head-elbow backward(4)/hand on head-elbow forward(6)/hand on head-elbow backward(8)/full elevation hand from head(10) Internal rotation: dorsal part of the hand reaching lateral thigh(0)/buttock(2)/lumbo-sacral junction(4)/L3(6)/Th12(8)/between scapulae(10). Abduction force at 90 degrees in pounds (max. 25)

Time frame: 1 year

Secondary Outcomes

Popeye phenomenon

Presence of a Popeye deformity in the upper arm (yes/no), as reported by the patient, the treating surgeon, and a blinded assessor.

Time frame: 1 year

Cosmetic appearance

Patients will assess cosmetic appearance on a VAS scale.

Time frame: 1 year

MRI-based location of the biceps tendon

MRI imaging at 1 year after surgery will be used to assess the location of the proximal biceps tendon. Absence of the biceps tendon in the bicipital groove confirms a successfully performed LHB tenotomy. Absence of the biceps tendon in the bicipital groove confirms failed LHB tendodesis. In addition, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.

Time frame: 1 year

Self-reported shoulder function

Patients will complete two validated questionnaires: the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Dutch Oxford Shoulder Test (DOST)

Data from ClinicalTrials.gov

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