Bankart LesionNCT03594071
S&P of Q-Fix™ All-Suture Anchor System
An observational study of Bankart Lesion and Acetabular Labrum Tear, run by Smith & Nephew, Inc. at 5 sites in United States.
Trial summary
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion
- What is being tested?
- The Q-Fix™ All-Suture Anchor
- Type of treatment
- Medical device
- How many people
- 294 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Aug 2018to 11 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: US sites
Who may be able to join
- Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
- Subject was ≥ 13 of age at time of surgery
Who cannot join
- Subject is ≤ 6 months post-operative
- Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northshore University Health System
Chicago, Illinois, 60201
Palmetto Health USC Orthopedic Center
Columbia, South Carolina, 29203
Tulane University Medical Center /Tulane Institute of Sport Medicine
New Orleans, Louisiana, 70112
Oklahoma Sports and Orthopedics Institute
Oklahoma City, Oklahoma, 73072
The Orthopaedic Center- Center for Advanced Orthopaedics
Washington D.C., District of Columbia, 20037
About this study
Official title: Safety and Performance of Q-Fix™ All-Suture Anchor System
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair
- Being tested
- The Q-Fix™ All-Suture Anchor
- Medical subject headings
- Bankart Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Q-Fix™ All-Suture AnchorDevice
Observational, post-market, clinical follow-up study
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
All individuals for whom the outcome of re-intervention is known at 6 months
Measured: 6 months
Secondary outcomes (7)
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon
All individuals for whom the outcome of re-intervention is known at 12 months
Measured: 12 months
Hip Visual Analog Scale (VAS) - Pain
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Measured: Screening, 6 months, and 12 months
Knee Visual Analog Scale (VAS) - Pain
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Measured: Screening, 6 months, and 12 months
Shoulder Visual Analog Scale (VAS) - Pain
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Measured: Screening, 6 months, and 12 months
Hip Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in hip by the physician.
Measured: Screening, 6 months, and 12 months
Knee Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in knee by the physician
Measured: Screening, 6 months, and 12 months
Shoulder Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.
Measured: Screening, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start31 Aug 2018
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bankart LesionStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Langone, Study chair, GBR - T. J. Smith and Nephew Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594071
- Sponsor's protocol ID
- 17-5010-11
- Status last verified
- Jan 2021
- First submitted
- 10 Jul 2018
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: * Study Protocol * Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Q-Fix™ All-Suture Anchor System
- ClinicalTrials.gov ID
- NCT03594071
- Acronym / sponsor ID
- 17-5010-11
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- US sites
Key inclusion criteria (2 listed)
- Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
- Subject was ≥ 13 of age at time of surgery
Key exclusion criteria (2 listed)
- Subject is ≤ 6 months post-operative
- Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
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 |
|---|---|---|
| The Q-Fix™ All-Suture AnchorObservational, post-market, clinical follow-up study | Device | – |
Primary outcome
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
Time frame: 6 months
All individuals for whom the outcome of re-intervention is known at 6 months
7 secondary outcomes
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon
Time frame: 12 months
Hip Visual Analog Scale (VAS) - Pain
Time frame: Screening, 6 months, and 12 months
Knee Visual Analog Scale (VAS) - Pain
Time frame: Screening, 6 months, and 12 months
Shoulder Visual Analog Scale (VAS) - Pain
Time frame: Screening, 6 months, and 12 months
Hip Range of Motion (ROM)
Time frame: Screening, 6 months, and 12 months
Knee Range of Motion (ROM)
Time frame: Screening, 6 months, and 12 months
Shoulder Range of Motion (ROM)
Time frame: Screening, 6 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. * Study Protocol * Clinical Study Report (CSR)
Related trials for Bankart Lesion
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Not yet recruitingObservational study
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic
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.
Lisa Langone study chair
GBR - T. J. Smith and Nephew Limited
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bankart Lesion and Acetabular Labrum Tear, run by Smith & Nephew, Inc. at 5 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon (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 9 Feb 2021.