- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870708
Arthroscopic Repair Of Partial Thickness Articular Side Rotator Cuff Tears Using Transtendon Versus Conversion Repair Techniques
March 10, 2025 updated by: Mohamed hussein khalil, Cairo University
This study aims to compare the functional results of patients who underwent two different arthroscopic methods for the management of articular-sided partial-thickness rotator cuff tears (PT-RCTs).
The present study aims to compare the functional results following the repair of PT-RCTs using the conversion versus the trastendon techniques
Study Overview
Status
Completed
Conditions
Detailed Description
This is a prospective randomized study carried out at a tertiary trauma center between October 2022 and June 2023.
The research ethical Committee authorized this study protocol [(Institutional Review Board (IRB) number: N-383-2023)], and all participants signed an informed consent prior to joining the study.
This study included 50 patients with PT-RCTs who underwent arthroscopic repair using either the conversion technique (25 patients) in group A or the transtendon technique (25 patients) in group B. The random assignment of all patients to enter either group was computerized using simple randomization.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
Cairo
-
Giza, Cairo, Egypt
- Faculty of Medicine, Cairo University
-
-
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
Accepts Healthy Volunteers
No
Description
The inclusion criteria were:
- Patients suffering symptomatic PT-RCTs exceeding 50% of the tendon thickness, documented by preoperative magnetic resonance imaging (MRI) and confirmed by arthroscopy intraoperative.
- Failure of nonoperative management for at least 3 months.
The exclusion criteria were:
- Prior shoulder surgery.
- Severe concomitant pathologies including glenohumeral arthritis, advanced subscapularis tear, and biceps tendon rupture.
- Associated Bankart lesion.
- Patients with uncontrolled Diabetes mellites.
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 |
|---|---|
|
Experimental: The Conversion repair technique: Group A
arthroscopic repair of partial rotator cuff tear using the conversion technique
|
arthroscopic repair of partial rotator cuff tear using the conversion versus the transtendon technique
|
|
Experimental: The Transtendon repair technique: Group B
arthroscopic repair of partial rotator cuff tear using the transtendon technique
|
arthroscopic repair of partial rotator cuff tear using the conversion versus the transtendon technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
American Shoulder and Elbow Surgeons score
Time Frame: baseline, and 18 months after surgery
|
shoulder score, the maximum is 100, the minimum is zero, a higher score means a better outcome
|
baseline, and 18 months after surgery
|
|
Constant and Murley score
Time Frame: baseline, and 18 months after surgery
|
shoulder score, the maximum is 100, the minimum is zero, a higher score means a better outcome
|
baseline, and 18 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale
Time Frame: baseline, and 18 months after surgery
|
pain score, the minimum is zero, the maximum is 10, the higher score means worse outcome
|
baseline, and 18 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mohamed H khalil, M.D, Cairo university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yang Y, Hu D, Chen S, Guan S, Shang X. Transtendon technique versus repair after completion of the tear for articular-sided partial rotator cuff tear: a meta-analysis of comparative studies. J Orthop Surg Res. 2023 May 22;18(1):378. doi: 10.1186/s13018-023-03831-4.
- Thamrongskulsiri N, Limskul D, Itthipanichpong T, Tanpowpong T, Kuptniratsaikul S. Similar outcomes between transtendon repair and tear completion repair techniques for partial articular-sided supraspinatus tendon avulsion lesions: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4575-4584. doi: 10.1007/s00167-023-07502-z. Epub 2023 Jul 15.
- Sun L, Zhang Q, Ge H, Sun Y, Cheng B. Which is the best repair of articular-sided rotator cuff tears: a meta-analysis. J Orthop Surg Res. 2015 May 28;10:84. doi: 10.1186/s13018-015-0224-6.
- Shin SJ. A comparison of 2 repair techniques for partial-thickness articular-sided rotator cuff tears. Arthroscopy. 2012 Jan;28(1):25-33. doi: 10.1016/j.arthro.2011.07.005. Epub 2011 Oct 14.
- Castagna A, Borroni M, Garofalo R, Rose GD, Cesari E, Padua R, Conti M, Gumina S. Deep partial rotator cuff tear: transtendon repair or tear completion and repair? A randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):460-3. doi: 10.1007/s00167-013-2536-6. Epub 2013 May 21.
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)
October 1, 2022
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
March 6, 2025
First Submitted That Met QC Criteria
March 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 10, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-383-2023
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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