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

NCT04538001 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-09-03

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears

Interventions

DEVICE

Balloon implantation

Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and balloon implantation.

PROCEDURE

Rotator cuff repair

Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and partial repair

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-03-01
Completion
2022-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538001 on ClinicalTrials.gov