Skillful Neglect Vs Repair For Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair.

NCT ID: NCT05960812

Last Updated: 2023-09-22

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

2022-09-30

Study Completion Date

2024-09-26

Brief Summary

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The purpose of this study is to compare functional outcomes of Skillful Neglect \& arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)

Detailed Description

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patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ASES score

Conditions

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Subscapularis Muscle Strain

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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group 1 (patient treated by skillful neglect with biceps tenotomy)

neglect of upper border subscapularis tear and doing biceps tenotomy

Group Type ACTIVE_COMPARATOR

skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

Intervention Type PROCEDURE

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.

* Semisetting position under GA.
* Standard shoulder arthroscopy with standard portals for RC repair.
* Inspection of articular surface of rotator cuff and biceps tendon.
* Bursectomy, visualization of all rotators.
* Mobilization is done for associated rotator tears by shaver and radiofrequency device.
* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
* Skillful neglect to the tear.
* Rotator repair technique by RC anchors
* Biceps Tenotomy will be done in all cases by cutting of LHBT.

arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

Intervention Type PROCEDURE

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.

* Semisetting position under GA.
* Standard shoulder arthroscopy with standard portals for RC repair.
* Inspection of articular surface of rotator cuff and biceps tendon.
* Bursectomy, visualization of all rotators.
* Mobilization is done for associated rotator tears by shaver and radiofrequency device.
* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
* Skillful neglect to the tear.
* Rotator repair technique by RC anchors
* Biceps Tenotomy will be done in all cases by cutting of LHBT.

group 2 (patient treated by arthroscopic repair with biceps tenotomy)

repair of upper border subscapularis tear and doing biceps tenotomy

Group Type ACTIVE_COMPARATOR

skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

Intervention Type PROCEDURE

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.

* Semisetting position under GA.
* Standard shoulder arthroscopy with standard portals for RC repair.
* Inspection of articular surface of rotator cuff and biceps tendon.
* Bursectomy, visualization of all rotators.
* Mobilization is done for associated rotator tears by shaver and radiofrequency device.
* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
* Skillful neglect to the tear.
* Rotator repair technique by RC anchors
* Biceps Tenotomy will be done in all cases by cutting of LHBT.

arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

Intervention Type PROCEDURE

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.

* Semisetting position under GA.
* Standard shoulder arthroscopy with standard portals for RC repair.
* Inspection of articular surface of rotator cuff and biceps tendon.
* Bursectomy, visualization of all rotators.
* Mobilization is done for associated rotator tears by shaver and radiofrequency device.
* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
* Skillful neglect to the tear.
* Rotator repair technique by RC anchors
* Biceps Tenotomy will be done in all cases by cutting of LHBT.

Interventions

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skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.

* Semisetting position under GA.
* Standard shoulder arthroscopy with standard portals for RC repair.
* Inspection of articular surface of rotator cuff and biceps tendon.
* Bursectomy, visualization of all rotators.
* Mobilization is done for associated rotator tears by shaver and radiofrequency device.
* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
* Skillful neglect to the tear.
* Rotator repair technique by RC anchors
* Biceps Tenotomy will be done in all cases by cutting of LHBT.

Intervention Type PROCEDURE

arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.

* Semisetting position under GA.
* Standard shoulder arthroscopy with standard portals for RC repair.
* Inspection of articular surface of rotator cuff and biceps tendon.
* Bursectomy, visualization of all rotators.
* Mobilization is done for associated rotator tears by shaver and radiofrequency device.
* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
* Skillful neglect to the tear.
* Rotator repair technique by RC anchors
* Biceps Tenotomy will be done in all cases by cutting of LHBT.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with combined upper subscapularis border tear in Lafosse type 1 and type 2.

Exclusion Criteria

* Glenohumeral arthritis.
* Patients with other intra-articular pathology like SLAP lesions.
* Neural damage (Brachial plexus injury).
* Revision cases.
* Patient with subscapularis border tear type 3, type 4, and type 5.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Ashraf Abdallah

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ashraf Abdallah

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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mohamed as abdallah, master

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Amr Mo Abdelhady

Role: STUDY_CHAIR

Ain Shams University

Maged Mo Samy

Role: STUDY_DIRECTOR

Ain Shams University

Mohamed Ha Sobhy

Role: STUDY_DIRECTOR

Ain Shams University

Yahia Mo Haroun

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed As Abdallah

Role: CONTACT

00201022677132

Yahia Mo Haroun

Role: CONTACT

00201006124615

Facility Contacts

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mohamed ashraf, master

Role: primary

00201022677132

Other Identifiers

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FMASU MD 218/2022

Identifier Type: -

Identifier Source: org_study_id

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