Shoulder PainNCT04093700
MDR SureLock All-Suture Anchor
An observational study of Shoulder Pain and Shoulder Injuries, run by Zimmer Biomet at 1 site in United States.
Trial summary
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Shoulder Pain, Shoulder Injuries, Shoulder Disease
- What is being tested?
- SureLock All-Suture Anchor
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 8 Nov 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects who underwent glenoid labrum repair with the SureLock all-suture anchors between 1/1/2014 and 12/31/2021.
Who may be able to join
- 14 to 45 years of age
- Surgery performed between 1/1/14-12/31/2021
- Recurrent shoulder instability resulting from an isolated anterior and/or posterior glenoid labral tear
- Completed pre-operative data (WOSI, ASES, SF-12)
Who cannot join
- Diagnosis of concomitant SLAP tear
- Diagnosis of concomitant full-thickness rotator cuff tear
- Greater than 10% loss of glenoid bone
- Greater than 25% humeral head defect
- Prior surgical intervention for the treatment of shoulder instability (in either the affected shoulder or the contralateral shoulder)
- Adults unable to consent
Show all 9Show fewer
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Health Research Institute
Lutherville, Maryland, 21093
About this study
Official title: Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
Read the detailed description
Patient-reported outcomes data have been collected among patients undergoing shoulder labrum repair with SureLock all-suture anchors from January 2014 to June 30, 2020. These patients have completed clinical and quality-of-life outcome instruments pre-operatively, and have been stored securely in the OBERD database. Pre-op scores will be compared to post-op scores and analyzed using a one-way ANOVA test with a post-hoc Scheffe procedure.
Patient identifying information will be removed and de-identified codes will be used. Any new prospective data gathered prospectively for the purposes of this study will be entered and stored securely as above.
Data collection forms will consist of the following Patient-Reported Outcome Surveys: WOSI Index, ASES Shoulder Score, and the SF-12.
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Disease, Shoulder Pain Chronic, Shoulder Syndrome, Labral Tear, Glenoid
- Being tested
- SureLock All-Suture Anchor
- Medical subject headings
- Shoulder Pain, Shoulder Injuries, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureLock All-Suture AnchorDevice
Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
| Study group | Role | What they receive |
|---|---|---|
| SureLock All-Suture Anchor | Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum Receives: Device: SureLock All-Suture Anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Performance and Benefits assessed through improvements in shoulder function
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the Western Ontario Shoulder Instability Index (WOSI) outcome measure. The WOSI is a 21-item scale used to measure shoulder related quality of life in patients with symptomatic shoulder instability.
Measured: Out to 1 year post-op
Device Performance and Benefits assessed through improvements in shoulder function
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the American Shoulder and Elbow Surgeon Score(ASES) outcome measure. The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Measured: Out to 1 year post-op
Secondary outcomes (2)
Device Benefits assessed through improvements of health-related quality of life.
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement of health-related quality of life through the SF-12. The SF-12 is a short survey that is weighted and summed to provide easily interpretable scaled for physical and mental health. The range is from 0-100, 0 being the lowest level of health and 100 indicates the highest level of health.
Measured: Out to 1 year post-op
Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events.
The assessment of safety and performance will be evaluated by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and Adverse Events. Relation of the events to either implant or instrumentation should be specified.
Measured: Out to 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start5 Nov 2019
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: The Sponsor decided that the CE marking would not be renewed, and therefore there was no longer a need to continue the study as the data was no longer necessary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093700
- Sponsor's protocol ID
- MDRG2017-89MS-90SM
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2019
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Surgical Repair of the Glenoid Labrum Using an All-Suture Anchor
- ClinicalTrials.gov ID
- NCT04093700
- Acronym / sponsor ID
- MDRG2017-89MS-90SM
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Disease, Shoulder Pain Chronic, Shoulder Syndrome, Labral Tear, Glenoid
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Sponsor decided that the CE marking would not be renewed, and therefore there was no longer a need to continue the study as the data was no longer necessary.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 18 Sep 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.
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
Detailed description
Patient-reported outcomes data have been collected among patients undergoing shoulder labrum repair with SureLock all-suture anchors from January 2014 to June 30, 2020. These patients have completed clinical and quality-of-life outcome instruments pre-operatively, and have been stored securely in the OBERD database. Pre-op scores will be compared to post-op scores and analyzed using a one-way ANOVA test with a post-hoc Scheffe procedure.
Patient identifying information will be removed and de-identified codes will be used. Any new prospective data gathered prospectively for the purposes of this study will be entered and stored securely as above.
Data collection forms will consist of the following Patient-Reported Outcome Surveys: WOSI Index, ASES Shoulder Score, and the SF-12.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SureLock All-Suture Anchor | – | Device: SureLock All-Suture AnchorSubjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects who underwent glenoid labrum repair with the SureLock all-suture anchors between 1/1/2014 and 12/31/2021.
Key inclusion criteria (4 listed)
- 14 to 45 years of age
- Surgery performed between 1/1/14-12/31/2021
- Recurrent shoulder instability resulting from an isolated anterior and/or posterior glenoid labral tear
- Completed pre-operative data (WOSI, ASES, SF-12)
Key exclusion criteria (9 listed)
- Diagnosis of concomitant SLAP tear
- Diagnosis of concomitant full-thickness rotator cuff tear
- Greater than 10% loss of glenoid bone
- Greater than 25% humeral head defect
- Prior surgical intervention for the treatment of shoulder instability (in either the affected shoulder or the contralateral shoulder)
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 |
|---|---|---|
| SureLock All-Suture AnchorSubjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum | Device | SureLock All-Suture Anchor |
Primary outcome
Device Performance and Benefits assessed through improvements in shoulder function
Time frame: Out to 1 year post-op
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the Western Ontario Shoulder Instability Index (WOSI) outcome measure. The WOSI is a 21-item scale used to measure shoulder related quality of life in patients with symptomatic shoulder instability.
Device Performance and Benefits assessed through improvements in shoulder function
Time frame: Out to 1 year post-op
Patients undergoing isolated anterior or posterior glenoid labrum repair using the SureLock All-Suture Anchor will experience statistically significant improvement in shoulder function assessed through the American Shoulder and Elbow Surgeon Score(ASES) outcome measure. The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
2 secondary outcomes
Device Benefits assessed through improvements of health-related quality of life.
Time frame: Out to 1 year post-op
Device Safety and Performance assessed through the frequency and incidence of revisions, complications and Adverse Events.
Time frame: Out to 1 year post-op
Results and safety
The study was stopped early (reason given: The Sponsor decided that the CE marking would not be renewed, and therefore there was no longer a need to continue the study as the data was no longer necessary.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Shoulder Pain and Shoulder Injuries, run by Zimmer Biomet at 1 site in United States.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Aug 2023. 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 United States. 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?
The study was stopped early (reason given: The Sponsor decided that the CE marking would not be renewed, and therefore there was no longer a need to continue the study as the data was no longer necessary.). 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?
Device Performance and Benefits assessed through improvements in shoulder function (time frame: Out to 1 year post-op). The study lists 2 primary outcomes in all. 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 14 Aug 2023.