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

NCT04538001 | Unknown DMC

• 1 other identifier: CHEER-I
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Constant-Murley shoulder outcome score

  Change in Constant-Murley shoulder outcome score and improvement compare to baseline

  6 months post operation

Secondary Outcomes (6)

• Change in Constant-Murley shoulder outcome score

  3 months, 1year post operation

• Change in American Shoulder and Elbow Score (ASES)

  3 months, 6 months and 1year post operation

• Change in pain score

  1 day, 6weeks, 3 months, 6months, 1year post operation

• Change in range of motion

  3 months, 6months, 1year post operation

• Acromiohumeral distance

  3 months, 6months, 1year post operation

Study Arms (2)

Balloon implantation

EXPERIMENTAL

Arthroscopic implantation of this sub-acromial balloon

Device: Balloon implantation

Rotator cuff repair

ACTIVE COMPARATOR

Partial rotator cuff repair

Procedure: Rotator cuff repair

Interventions

Balloon implantation DEVICE

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

Balloon implantation

Rotator cuff repair PROCEDURE

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

Rotator cuff repair

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months
• Failed non-operative treatment of at least 3 months
• Patients are able to understand the purpose of the trial, voluntarily participated in and acknowledged the risks and benefits by signing the informed consent form
• Patients can complete the clinical trial psychologically, physiologically and mentally, and can comply with all post-operative evaluations and visits
• Posterosuperior rotator cuff tear diagnosed by MRI in the past 6 months, defined as the rotator cuff tear involving supraspinatus and infraspinatus muscles, and could be combined with type I subscapular muscle injury.
• Evidence of any one of the following conditions confirmed by MRI:

You may not qualify if:

• Known allergy to the balloon material (polyethylene)
• Evidence of osteoarthritis or cartilage damage in the shoulder
• Evidence of gleno-humeral instability or axillary nerve palsy
• Evidence of major joint trauma, infection, or necrosis in the shoulder
• Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
• Shoulder pain due to other unknown causes
• Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
• Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
• Acute infection requiring antibiotics
• Subjects receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
• Subjects with implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators) or other contraindications for MRI scan
• Severe dysfunction in heart, brain, lungs or kidney and cannot tolerate surgery.
• Severe disorder in bleeding or coagulation function that cannot be corrected.
• Pregnancy
• Subjects being suffered from other serious illness which may affect quality of life the results of the study (e.g. HIV, active malignancy in the past 5 years, transmural myocardial infarction in 6 months, unstable angina pectoris, CVA, renal insufficiency, etc.)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Jinzhong ZHAO, Professor

CONTACT

13917396491; zhaojinzhong@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: September 3, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: * (With) Researchers who provide a methodologically sound proposal. * (For the analysis) to achieve aims in the approved proposal. * (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).