Rotator Cuff TearsNCT04538001
Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear
A study testing Balloon implantation and Rotator cuff repair in people with Rotator Cuff Tears, run by Shanghai MicroPort Medical (Group) Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Balloon implantation and Rotator cuff repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Balloon implantation, Rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon implantationDevice
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 repairProcedure or surgery
Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and partial repair
| Study group | Role | What they receive |
|---|---|---|
| Balloon implantation | Experimental | Arthroscopic implantation of this sub-acromial balloon Receives: Device: Balloon implantation |
| Rotator cuff repair | Active comparator | Partial rotator cuff repair Receives: Procedure: Rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant-Murley shoulder outcome score
Change in Constant-Murley shoulder outcome score and improvement compare to baseline
Measured: 6 months post operation
Secondary outcomes (6)
Change in Constant-Murley shoulder outcome score
Change in Constant-Murley shoulder outcome score and improvement compare to baseline at each time point
Measured: 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
Measured: 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
Measured: 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)
Measured: 3 months, 6months, 1year post operation
Acromiohumeral distance
The distance between the acromion and the proximal humerus
Measured: 3 months, 6months, 1year post operation
Safety assessment
The Safety assessment will include the incidence of AEs/SAEs throughout the entire study period
Measured: Peri-operation and 1 day, 6weeks, 3 months, 6months, 1year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538001
- Sponsor's protocol ID
- CHEER-I
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow: (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). If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04538001
- Acronym / sponsor ID
- CHEER-I
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon implantation | Experimental | Device: Balloon implantationArthroscopic implantation of this sub-acromial balloon |
| Rotator cuff repair | Active comparator | Procedure: Rotator cuff repairPartial rotator cuff repair |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon implantationSubjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and balloon implantation. | Device | Balloon implantation |
| Rotator cuff repairSubjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and partial repair | Procedure or surgery | Rotator cuff repair |
Primary outcome
Change in Constant-Murley shoulder outcome score
Time frame: 6 months post operation
Change in Constant-Murley shoulder outcome score and improvement compare to baseline
6 secondary outcomes
Change in Constant-Murley shoulder outcome score
Time frame: 3 months, 1year post operation
Change in American Shoulder and Elbow Score (ASES)
Time frame: 3 months, 6 months and 1year post operation
Change in pain score
Time frame: 1 day, 6weeks, 3 months, 6months, 1year post operation
Change in range of motion
Time frame: 3 months, 6months, 1year post operation
Acromiohumeral distance
Time frame: 3 months, 6months, 1year post operation
Safety assessment
Time frame: Peri-operation and 1 day, 6weeks, 3 months, 6months, 1year post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow: (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). If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon implantation and Rotator cuff repair in people with Rotator Cuff Tears, run by Shanghai MicroPort Medical (Group) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinzhong ZHAO, Professor (13917396491, zhaojinzhong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constant-Murley shoulder outcome score (time frame: 6 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.