Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Study Overview
=================
Brief Summary
-----------------
Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.

Official Title
-----------------
A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: double layer fixation
* Procedure: single layer fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation tear size of at least 2.5 cm and up to 4.0 cm signed informed consent Exclusion Criteria: axillary nerve palsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: double layer fixation<br>Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation | Procedure: double layer fixation<br> <br> |
| Experimental: single layer fixation<br>Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation | Procedure: single layer fixation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retear rate | Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups | 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley score | Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups | baseline, 24 and 60 months postoperatively | 
| Range of motion (ROM) | Comparison of ROMs between groups | baseline, 24 and 60 months postoperatively | 
| Satisfaction with the procedure | Comparison of satisfaction with the procedure between groups. Satisfaction is evaluated by asking patients one question to rate their satisfaction with the procedure based on a likert scale (4 = 'very satisfied', 3 = 'quite satisfied', 2 = 'moderately satisfied', 1 = 'less satisfied', 0 = 'not at all satisfied'). | 24 and 60 months postoperatively | 
| VAS | Comparison of the Visual Analogue Scale (VAS) between groups | baseline, 24 and 60 months postoperatively | 
| SST | Comparison of the Simple Shoulder Test (SST) between groups | baseline and 24 months postoperatively | 
| ASES | Comparison of the American Shoulder and Elbow Surgeons score (ASES) between groups. The ASES is a patient-rated questionnaire with a total between 0 and 100 points with higher scores indicating better outcome. | baseline, 24 and 60 months postoperatively | 
| qDASH | Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups | baseline, 24 and 60 months postoperatively | 
| WORC | Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups | baseline and 24 months postoperatively | 
| SSV | Comparison of the Simple Soulder Value (SSV) between groups | baseline, 24 and 60 months postoperatively | 
| SF-36 | Comparison of the quality-of-life score short form 36 (SF-36) between groups | baseline, 24 and 60 months postoperatively | 
| Tendon integrity | Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups | baseline and 60 months postoperatively |