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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Arthroscopic massive rotator cuff repair

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

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Massive cuff tears, Biceps autograft, Arthroscopic repair partial or complete, Retear, Superior capsular augmentation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mostafa Ahmed Mohamed Mostafa,MSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation

Arm Description

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)

• 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

Outcomes

Primary Outcome Measures

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.)

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05817071

First Posted

January 6, 2023

Last Updated

July 21, 2023

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05817071

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 15, 2022 (Actual)

Primary Completion Date

June 15, 2023 (Actual)

Study Completion Date

January 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation

Arm Type

Experimental

Arm Description

• 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

Intervention Type

Procedure

Intervention Name(s)

Arthroscopic massive rotator cuff repair

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Functional shoulder constant score (assess the change pre operative and post operative during study period completion)

Description

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.)

Time Frame

1- preoperative 2- six months post operative 3- one year post operative

Title

Functional shoulder ases score (assess the change preoperative and postoperative during study period completion )

Description

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.

Time Frame

1- preoperative 2- six months post operative 3- one year post operative

Secondary Outcome Measure Information:

Title

Shoulder Pain ( assess the change preoperative and postoperative during the study period completion)

Description

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

Time Frame

1 pre operative 2 two weeks post operative 3 six months post operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: