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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Device: Balloon implantation
* Procedure: Rotator cuff repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: (1) The rotator cuff tear measuring >3cm in size; (2) involving ≥ 2 tendons; (3) stage 3 or 4 fatty infiltration according to Goutallier Classification; (4) acromiohumeral interval <7mm. 7. All subjects meeting the above inclusion criteria will undergo arthroscopic debridement, if the tear size is still >3cm at medial to lateral direction, and the superior edge cannot be fixed to the footprint area to overlap bone coverage for complete repair. Exclusion Criteria: 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. 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. 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.) Diseases or other conditions which cannot finish 1 year follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon implantation<br>Arthroscopic implantation of this sub-acromial balloon | Device: Balloon implantation<br>* Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and balloon implantation.<br>|
| Active Comparator: Rotator cuff repair<br>Partial rotator cuff repair | Procedure: Rotator cuff repair<br>* Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and partial repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Constant-Murley shoulder outcome score | Change in Constant-Murley shoulder outcome score and improvement compare to baseline | 6 months post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Constant-Murley shoulder outcome score | Change in Constant-Murley shoulder outcome score and improvement compare to baseline at each time point | 3 months, 1year post operation | 
| Change in American Shoulder and Elbow Score (ASES) | Change in American Shoulder and Elbow Score (ASES) and improvement compare to baseline at each time point | 3 months, 6 months and 1year post operation | 
| Change in pain score | Change in Visual Analog Scale pain score and improvement compare to baseline at each time point | 1 day, 6weeks, 3 months, 6months, 1year post operation | 
| Change in range of motion | Change in range of motion and improvement compare to baseline at each time point, including active shoulder flexion and extension (from ASES score) | 3 months, 6months, 1year post operation | 
| Acromiohumeral distance | The distance between the acromion and the proximal humerus | 3 months, 6months, 1year post operation | 
| Safety assessment | The Safety assessment will include the incidence of AEs/SAEs throughout the entire study period | Peri-operation and 1 day, 6weeks, 3 months, 6months, 1year post operation |