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

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Procedure: Arthroscopic massive rotator cuff repair; Procedure: Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon

• Registration Number: NCT05817071
• Lead Sponsor: Ain Shams University

Brief Summary

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

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).

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-01-06
• Status Verified: 2023-03
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Primary Completion: 2023-06-15
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Study Completion: 2024-01-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation	Arthroscopic massive rotator cuff repair	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)
Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation	Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon	• 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

Primary Outcome Measures

Name	Time	Method
Functional shoulder constant score (assess the change pre operative and post operative during study period completion)	1- preoperative 2- six months post operative 3- one year post operative	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.)
Functional shoulder ases score (assess the change preoperative and postoperative during study period completion )	1- preoperative 2- six months post operative 3- one year post operative	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.

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain ( assess the change preoperative and postoperative during the study period completion)	1 pre operative 2 two weeks post operative 3 six months post operative	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

Trial Locations

Locations (1)

Mostafa Ahmed Mohamed Mostafa,MSC; 🇪🇬 Cairo, Abbasia, Egypt