Clinical Trials Logo
  1. Home
  2. Rotator Cuff Tears
  3. NCT04710966

Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears

Rotator Cuff Tears Clinical Trial

Official title:
Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial

Clinical Trial Summary

The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.

Clinical Trial Description

This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04710966
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact
Status Completed
Phase N/A
Start date September 1, 2017
Completion date November 15, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04974242 - Physiotherapy for Patients Awaiting Rotator Cuff Repair N/A
Recruiting NCT06055478 - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair N/A
Completed NCT04552925 - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears N/A
Not yet recruiting NCT06032416 - DenCT Shoulder Bone Quality Evaluation N/A
Not yet recruiting NCT04047745 - Post-operative Exparel Study Following Rotator Cuff Repair N/A
Completed NCT01029574 - Platelet Rich Plasma on Rotator Cuff Repair Phase 3
Not yet recruiting NCT05817578 - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Suspended NCT04421417 - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing N/A
Recruiting NCT06156423 - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery N/A
Completed NCT06145815 - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting NCT05009498 - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A
Not yet recruiting NCT04584476 - Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears N/A