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

NCT ID: NCT04538001

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-01

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.

Detailed 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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Balloon implantation

Arthroscopic implantation of this sub-acromial balloon

Group Type: EXPERIMENTAL

Balloon implantation

Intervention Type: DEVICE

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

Rotator cuff repair

Partial rotator cuff repair

Group Type: ACTIVE_COMPARATOR

Rotator cuff repair

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months

2. Failed non-operative treatment of at least 3 months

3. 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

4. Patients can complete the clinical trial psychologically, physiologically and mentally, and can comply with all post-operative evaluations and visits

5. 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.

6. Evidence of any one of the following conditions confirmed by MRI:

Exclusion Criteria

1. Known allergy to the balloon material (polyethylene)

2. Evidence of osteoarthritis or cartilage damage in the shoulder

3. Evidence of gleno-humeral instability or axillary nerve palsy

4. Evidence of major joint trauma, infection, or necrosis in the shoulder

5. Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy

6. Shoulder pain due to other unknown causes

7. Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.

8. Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons, or considered not to be suitable for inclusion by investigators.

9. Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.

10. Acute infection requiring antibiotics

11. Subjects receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition

12. Subjects with implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators) or other contraindications for MRI scan

13. Severe dysfunction in heart, brain, lungs or kidney and cannot tolerate surgery.

14. Severe disorder in bleeding or coagulation function that cannot be corrected.

15. Pregnancy

16. 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.)

17. Diseases or other conditions which cannot finish 1 year follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jinzhong ZHAO, Professor

Role: CONTACT

zhaojinzhong@vip.163.com

13917396491

Other Identifiers

CHEER-I

Identifier Type: -

Identifier Source: org_study_id