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

Not Applicable

Completed

• Conditions: Rotator Cuff Syndrome
• Interventions: Procedure: Arthroscopic rotator cuff repair; Procedure: LHB Tenotomy; Procedure: LHB Tenodesis

• Registration Number: NCT02655848
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-14
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
@ cuff repair with LHB tenotomy	Arthroscopic rotator cuff repair	In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.
@ Cuff repair with LHB tenodesis	Arthroscopic rotator cuff repair	In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.
@ cuff repair with LHB tenotomy	LHB Tenotomy	In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.
@ Cuff repair with LHB tenodesis	LHB Tenodesis	In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.

Primary Outcome Measures

Name	Time	Method
Shoulder function quantified with the Constant score (0-100)	1 year	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)

Secondary Outcome Measures

Name	Time	Method
Elbow flexion strength	1 year	A dynamometer will be used to assess elbow flexion strength with the lower arm in full supination. The Elbow Strength Index is calculated by dividing the strength in the affected side by the strength in the contralateral side.
Popeye phenomenon	1 year	Presence of a Popeye deformity in the upper arm (yes/no), as reported by the patient, the treating surgeon, and a blinded assessor.
Cosmetic appearance	1 year	Patients will assess cosmetic appearance on a VAS scale.
Self-reported shoulder function	1 year	Patients will complete two validated questionnaires: the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Dutch Oxford Shoulder Test (DOST)
Duration of surgery	1 year	The duration of surgery will be calculated based on the start and end times of each surgery.
MRI-based location of the biceps tendon	1 year	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.
Pain	1 year	Patients will be asked to report if they have pain (yes/no), and to indicate the level of pain on a VAS scale. The VAS scores will be recorded separately for general pain and for pain in the bicipital groove.
Quality of life	1 year	Patients will complete the validated questionnaire 'EQ-5D', which covers 5 domains (mobility, personal care, daily activities, pain and mood), as well as a 100 point thermometer on general health.
Complications	1 year	All complications and serious adverse events in the study population are recorded.
Post-operative status of rotator cuff	1 year	Based on MRI imaging at 1 year after surgery, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.

Trial Locations

Locations (10)

Slootervaart ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Tergooi Ziekenhuizen; 🇳🇱 Hilversum, Netherlands

Spaarne Ziekenhuis; 🇳🇱 Hoofddorp, Netherlands

Canisius Wilehelmina Zkh; 🇳🇱 Nijmegen, Netherlands

Kliniek De Lairesse; 🇳🇱 Amsterdam, Netherlands

Gelre ziekenhuis; 🇳🇱 Apeldoorn, Netherlands

Amphia ziekenhuis; 🇳🇱 Breda, Netherlands

OLVG; 🇳🇱 Amsterdam, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

St Antonius; 🇳🇱 Nieuwegein, Netherlands