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

NCT05817071 | Unknown

• 1 other identifier: FMASU MD 246/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Rotator Cuff Tears

Keywords

Massive cuff tears; Biceps autograft; Arthroscopic repair partial or complete; Retear; Superior capsular augmentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation

ACTIVE COMPARATOR

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 Tears Repair With biceps Augmentation

EXPERIMENTAL

• 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

Interventions

Arthroscopic massive rotator cuff repair PROCEDURE

Arthroscopic massive rotator cuff repair without biceps tendon augmentation either partial or complete repair.

Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation

Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon PROCEDURE

Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon .

Also known as: Superior capsular augmentation using proximal part of the long head of biceps tendon ( LHBT), Biceps tendon autograft technique.

Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 40 to 80 years old
• Patients with massive rotator cuff tear

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Mostafa Ahmed Mohamed Mostafa,MSC

Cairo, Abbasia, 11539, Egypt

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Amr Mo Abdelhady, Professor

  Faculty of medicine Ain shams university

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Mostafa Ah Mostafa

  Faculty of medicine Ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: April 18, 2023
• Study Start: December 15, 2022
• Primary Completion: June 15, 2023
• Study Completion: January 14, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)