Results of Arthroscopic Massive Rotator Cuff Tears Repair With or Without Using Long Head of Biceps Tendon

Study Overview
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Brief Summary
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The Goal of this clinical trial is to asses the function of arthroscopic repair with or without superior capsular augmentation using biceps tendon .

Detailed Description
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All patients included in this clinical trial Will be informed by written consent will undergo a one week screening to determine the eligibility for study entry. Patients who meet the eligibility requirements Will be randomised in a single blinded manner ( patients).

Official Title
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Results of Arthroscopic Massive Rotator Cuff Tears Repair With Or Without Superior Capsular Augmentation Using Proximal Part Of Long Head Of Biceps Tendon: A Randomized Controlled Trial

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Procedure: Arthroscopic massive rotator cuff repair
* Procedure: Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 40 to 80 years old Patients with massive rotator cuff tear Exclusion Criteria: patients with glenohumeral arthritis Acromioclavicular arthritis that requires distal clavicle resection Patients with other intra articular pathology like slap lesion Neural damage( brachial plexus injury) Revision cases

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation<br>Arthroscopic repair either complete or partial with medialization or not by anchors without using proximal part of long head of biceps tendon) ( single row or double row )(partial or complete anatomical) | Procedure: Arthroscopic massive rotator cuff repair<br>* Arthroscopic massive rotator cuff repair without biceps tendon augmentation either partial or complete repair.<br>|
| Experimental: Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation<br>• Single or double row repair technique by Rotator Cuff(RC) anchors. Biceps augmentation will be done via release and mobilize the Long Head of Biceps Tendon from bicipital groove. then the proximal part of long head of biceps tendon will be lateralized towards greater tuberosity crossing the gap by passing 1 limb of the RC anchor using suture passer (scorpion or lasso loop) and the other limb of the same anchor was passed through torn cuff. a horizontal limb of distal part biceps tendon was interpositioned between the Rotator Cuff Tears And humeral head, aiding in biological healing and strengthening poor quality rotator cuff tendons | Procedure: Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon<br>* Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon .<br>* Other names: Biceps tendon autograft technique.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional shoulder constant score (assess the change pre operative and post operative during study period completion) | Assess the change of Constant score of the patients pre operative and during follow up duration of the study on multiple periods (a multi-item functional scale assessing pain, activity of daily living , range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.) | 1- preoperative 2- six months post operative 3- one year post operative | 
| Functional shoulder ases score (assess the change preoperative and postoperative during study period completion ) | Assess the change in Ases score pre operative and post operative during study completion on multiple periods ( American shoulder and elbow surgeons standardized form)Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. | 1- preoperative 2- six months post operative 3- one year post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain ( assess the change preoperative and postoperative during the study period completion) | Asses the change in the visual analog score ( zero equal no pain and 10 equal severest pain ) pre operative and post operative during study period on different periods | 1 pre operative 2 two weeks post operative 3 six months post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massive cuff tears, Biceps autograft, Arthroscopic repair partial or complete, Retear, Superior capsular augmentation