Shoulder Instability Rotator Cuff InjuryMST-002NCT04121663
Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery
A study testing Total arthroscopic rotator cuff repair in people with Shoulder Instability Rotator Cuff Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Instability Rotator Cuff Injury
- What is being tested?
- Total arthroscopic rotator cuff repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2019to 31 Oct 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation
- Patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor
- Subjects were willing and able to sign informed consent
Who cannot join
- Patients with severe osteoporosis；
- A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation；
- Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)；
- Patients with abnormal liver and kidney function [SGPT (ALT) or SGOT (AST) or creatinine (CR)] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (PT) prolonged or shortened > 3 s, activated partial thromboplastin time (aPTT) prolonged or shortened > 10 s, platelet count (PLT) < 50 *109/L)；
- Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study；
- Cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with；
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- Pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure；
- Surgical site peripheral nerve injury；
- Subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint
- High blood pressure control is still not suitable for surgery；
- Malignant Tumor Patients；
- Researchers believe that there are other circumstances that are not suitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery
Read the detailed description
This clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by Hangzhou Ruijian Mastine Medical Equipment Co., Ltd. and the polyether ether ketone bone anchor system made by Arthrex, Inc., USA, and evaluates the safety and effectiveness of the experimental device in clinical application
- Conditions
- Shoulder Instability Rotator Cuff Injury
- Being tested
- Total arthroscopic rotator cuff repair
- Keywords
- Shoulder instability, Rotator cuff injury
- 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.
Total arthroscopic rotator cuff repairDevice
The equivalence of the two devices was compared by using control and experimental instruments during the operation
| Study group | Role | What they receive |
|---|---|---|
| Full seam anchor | Experimental | Not described Receives: Device: Total arthroscopic rotator cuff repair |
| Polyether ether ketone bone anchor | Active comparator | Not described Receives: Device: Total arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA score
Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%
Measured: 6 months
Secondary outcomes (3)
UCLA score
Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%
Measured: 3 months
constant-murley score
The higher the score, the better shoulder function.
Measured: 3 months
ASES score
The higher the score, the better shoulder function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start22 Sep 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Instability Rotator Cuff InjuryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121663
- Sponsor's protocol ID
- 2018-159
- Acronym
- MST-002
- Status last verified
- Jun 2019
- First submitted
- 25 Sep 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery
- ClinicalTrials.gov ID
- NCT04121663
- Acronym / sponsor ID
- MST-002 / 2018-159
- Conditions
- Shoulder Instability Rotator Cuff Injury
- Keywords
- Shoulder instability, Rotator cuff injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 22 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 10 Oct 2019 (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.
Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery
Detailed description
This clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by Hangzhou Ruijian Mastine Medical Equipment Co., Ltd. and the polyether ether ketone bone anchor system made by Arthrex, Inc., USA, and evaluates the safety and effectiveness of the experimental device in clinical application
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full seam anchor | Experimental | Device: Total arthroscopic rotator cuff repair |
| Polyether ether ketone bone anchor | Active comparator | Device: Total arthroscopic rotator cuff repair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation
- Patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor
- Subjects were willing and able to sign informed consent
Key exclusion criteria (12 listed)
- Patients with severe osteoporosis；
- A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation；
- Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)；
- Patients with abnormal liver and kidney function [SGPT (ALT) or SGOT (AST) or creatinine (CR)] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (PT) prolonged or shortened > 3 s, activated partial thromboplastin time (aPTT) prolonged or shortened > 10 s, platelet count (PLT) < 50 *109/L)；
- Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study；
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 |
|---|---|---|
| Total arthroscopic rotator cuff repairThe equivalence of the two devices was compared by using control and experimental instruments during the operation | Device | Full seam anchor, Polyether ether ketone bone anchor |
Primary outcome
UCLA score
Time frame: 6 months
Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%
3 secondary outcomes
UCLA score
Time frame: 3 months
constant-murley score
Time frame: 3 months
ASES score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total arthroscopic rotator cuff repair in people with Shoulder Instability Rotator Cuff Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 12 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA score (time frame: 6 months). 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 10 Oct 2019.