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

NCT ID: NCT05817071

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-01-14

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).

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Arthroscopic massive rotator cuff repair

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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Arthroscopic massive rotator cuff repair

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

Intervention Type 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 .

Intervention Type PROCEDURE

Other Intervention Names

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

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amr Mo Abdelhady, Professor

Role: STUDY_CHAIR

Faculty of medicine Ain shams university

Mohamed Ha Sobhy, Professor

Role: STUDY_DIRECTOR

Faculty of medicine Ain shams university

Ahmed Ha Khater, professor

Role: STUDY_DIRECTOR

Faculty of medicine Ain shams university

Yahia Mo Haroun, Lecturer

Role: STUDY_DIRECTOR

Faculty of medicine Ain shams university

Mostafa Ah Mostafa

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine Ain shams university

Locations

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Mostafa Ahmed Mohamed Mostafa,MSC

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MD 246/2021

Identifier Type: -

Identifier Source: org_study_id

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