Arthroscopic Repair of Partial Thickness Articular-Side Rotator Cuff Tears: Transtendon Versus Conversion Repair Techniques
Arthroscopic Repair of Partial Thickness Articular Side Rotator Cuff Tears Using Transtendon Versus Conversion Repair Techniques.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Kasr AlAiny
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Conversion Repair
Patients with PT-RCTs treated using the arthroscopic conversion technique.
|
Patients undergo arthroscopic conversion repair, where the partial-thickness tear is converted to a full-thickness tear and repaired using standard arthroscopic techniques.
|
|
Active Comparator: Transtendon Repair
Patients with PT-RCTs treated using the arthroscopic transtendon repair technique.
|
Patients undergo arthroscopic transtendon repair, preserving the intact bursal surface of the tendon while repairing the articular-side defect using suture anchors.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Baseline and 24 months postoperatively
|
Baseline and 24 months postoperatively
|
|
Constant-Murley Score (CMS)
Time Frame: Baseline and 24 months postoperatively
|
Baseline and 24 months postoperatively
|
|
Visual Analogue Scale (VAS) for Pain
Time Frame: Baseline and 24 months postoperatively
|
Baseline and 24 months postoperatively
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion (ROM)
Time Frame: Preoperative and 24 months postoperatively.
|
Measure the range of:
|
Preoperative and 24 months postoperatively.
|
|
Complication Rate
Time Frame: Up to 24 months postoperatively
|
Number of cases with: Stiffness Persistent pain Infection |
Up to 24 months postoperatively
|
|
MRI Healing Status
Time Frame: 12 months postoperatively
|
Number of cases with complete healing in MRI
|
12 months postoperatively
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- N-383-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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