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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Arthroscopic massive rotator cuff repair; Procedure: Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Ah Mohamed, Researcher; Phone Number: +201099436335; Email: mostafa_ahmedmostafa@med.asu.edu.eg
• Study Contact Backup: Name: Yahia Mo Haroun, Lecturer; Phone Number: +20 100 612 4615; Email: yahiaharoon@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11539
      • Mostafa Ahmed Mohamed Mostafa,MSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation; 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; Arthroscopic massive rotator cuff repair without biceps tendon augmentation either partial or complete repair.
Experimental: Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation; • 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; Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon .; Other Names: Superior capsular augmentation using proximal part of the long head of biceps tendon ( LHBT); Biceps tendon autograft technique.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Amr Mo Abdelhady, Professor, Faculty of Medicine Ain shams University; Study Director: Mohamed Ha Sobhy, Professor, Faculty of Medicine Ain shams University; Study Director: Ahmed Ha Khater, professor, Faculty of Medicine Ain shams University; Study Director: Yahia Mo Haroun, Lecturer, Faculty of Medicine Ain shams University; Principal Investigator: Mostafa Ah Mostafa, Faculty of Medicine Ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Estimated): January 14, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Massive cuff tears; Biceps autograft; Arthroscopic repair partial or complete; Retear; Superior capsular augmentation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: FMASU MD 246/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No