Clinical Trials Logo
  1. Home
  2. Rotator Cuff Tears
  3. NCT04538001

Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear

Rotator Cuff Tears Clinical Trial

Official title:
A Prospective, Multicenter, Randomized Trial in Evaluating the Safety and Efficacy of the Rotator Cuff Function Restoration Balloon in Patients With Irreparable Rotator Cuff Tear

Clinical Trial Summary

This study is a prospective, multicenter, randomized, controlled clinical study aiming to evaluate the safety and efficacy of the rotator cuff function restoration balloon in patients with irreparable rotator cuff tear compared to partial repair of the rotator cuff.

Clinical Trial Description

This prospective, multicenter, randomized controlled clinical study is designed to enroll 112 subjects with irreparable rotator cuff tear and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with rotator cuff restoration balloon, and the control group was treated with rotator cuff partial repair. The main end point of the study was improvement of the Constant Score at 6 months after the surgery. All subjects were followed up clinically at 1 day, 6 weeks, 3 months, 6 months and 1 year after the surgery, and were followed up with imaging examination at 3 months, 6 months and 1 year after the surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04538001
Study type Interventional
Source Shanghai MicroPort Medical (Group) Co., Ltd.
Contact Jinzhong ZHAO, Professor
Phone 13917396491
Email zhaojinzhong@vip.163.com
Status Not yet recruiting
Phase N/A
Start date September 1, 2020
Completion date September 1, 2022
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
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears 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 NCT04584476 - Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A