Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques

June 12, 2024 updated by: Hossam Eldin Mohamed Ahmed ElAzab, Sohag University
rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

accompanied by shoulder pain and dysfunction

Study Type

Interventional

Enrollment (Actual)

89

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 Locations

  • Egypt
      • Sohag, Egypt, 82511
        • University Hospital

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:

  • full-thickness supraspinatus
  • degenerative tears
  • age range 40 :65

Exclusion Criteria:

  • subscapularis tear
  • small and massive tears
  • traumatic tears
  • partial -thickness tear
  • revisioin surgery
  • glenohumeral arthretic changes and shoulder instability

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: knotless group
rotator cuff repair with a modified knotless anchors
Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
rotator cuff tears with modified versus classic double row suture bridge
Active Comparator: knot-tying group
rotator cuff repair with classic knot-tying double-row suture bridge technique by classic anchors
Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
rotator cuff tears with modified versus classic double row suture bridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retear rate
Time Frame: 3 years
retear rate
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time
Time Frame: 3 years
duration of operation
3 years

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Study Chair: Hossam M azab, MD, Sohag 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)

July 1, 2018

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-01

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.

Clinical Trials on Rotator Cuff Tears

Clinical Trials on Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe