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

September 21, 2023 updated by: Mohamed Ashraf Abdallah

Skillful Neglect Vs Repair For Upper Border Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair In Non-Athletes: A Randomized Controlled Trial

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yahia Mo Haroun
  • Phone Number: 00201006124615

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1 (patient treated by skillful neglect with biceps tenotomy)
neglect of upper border subscapularis tear and doing biceps tenotomy
Procedure: 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.
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.
Active Comparator: group 2 (patient treated by arthroscopic repair with biceps tenotomy)
repair of upper border subscapularis tear and doing biceps tenotomy
Procedure: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
american shoulder elbow score
Time Frame: after 6months and 12 months
scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.
after 6months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue score
Time Frame: Post operative 6months and 12 months
subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Post operative 6months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Ashraf Abdallah

Investigators

  • Principal Investigator: mohamed as abdallah, master, Ain Shams University
  • Study Chair: Amr Mo Abdelhady, Ain Shams University
  • Study Director: Maged Mo Samy, Ain Shams University
  • Study Director: Mohamed Ha Sobhy, Ain Shams University
  • Study Director: Yahia Mo Haroun, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Estimated)

September 26, 2024

Study Completion (Estimated)

September 26, 2024

Study Registration Dates

First Submitted

May 20, 2023

First Submitted That Met QC Criteria

July 22, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU MD 218/2022

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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