An interventional study of Arthroscopic rotator cuff repair and LHB Tenodesis in Rotator Cuff Syndrome, sponsored by Onze Lieve Vrouwe Gasthuis. Completed at 10 sites in Netherlands. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Onze Lieve Vrouwe Gasthuis · Not applicable, Interventional, and Treatment
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.
Onze Lieve Vrouwe Gasthuis is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.
Procedure: Arthroscopic rotator cuff repair · Procedure: LHB Tenodesis
In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.
Procedure: Arthroscopic rotator cuff repair · Procedure: LHB Tenotomy
Arthroscopic rotator cuff repair using suture anchors
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
Arthroscopic tenotomy of long head biceps
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
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)
Time frame: 1 year
Pain
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.
Time frame: 1 year
Elbow flexion strength
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.
Time frame: 1 year
Quality of life
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.
Time frame: 1 year
Post-operative status of rotator cuff
Based on MRI imaging at 1 year after surgery, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.
Time frame: 1 year
Duration of surgery
The duration of surgery will be calculated based on the start and end times of each surgery.
Time frame: 1 year
Complications
All complications and serious adverse events in the study population are recorded.
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Onze Lieve Vrouwe Gasthuis