Hallux Valgus RepairsMINITACNCT04186481
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
An observational study of Hallux Valgus Repairs and Medial or Lateral Instability Repairs/Reconstructions, run by Smith & Nephew, Inc. at 1 site in Australia.
Trial summary
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions
- What is being tested?
- MINITAC Ti 2.0 suture anchor
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Oct 2019to 8 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
- Subject was ≥ 18 years of age at time of surgery.
- Subject status is > 12 months post-operative.
Who cannot join
- 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
1 site in 1 country.
Australia1 site
Maitland Hand and Othopaedic surgery
Ashtonfield, New South Wales, 2323
About this study
Official title: Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
Read the detailed description
Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Scapholunate Ligament Reconstructions
- Being tested
- MINITAC Ti 2.0 suture anchor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINITAC Ti 2.0 suture anchorDevice
The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
| Study group | Role | What they receive |
|---|---|---|
| Minitac Ti 2.0 suture anchor | Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor Receives: Device: MINITAC Ti 2.0 suture anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
Measured: 6 months
Secondary outcomes (1)
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon for all participants that completed the 12-month visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start25 Oct 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 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 Hallux Valgus RepairsStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc), Principal investigator, Maitland Hand and Othopaedic surgeryStephan Mangin, Study chair, Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186481
- Sponsor's protocol ID
- MINI.PMCF.2018.11
- Acronym
- MINITAC
- Status last verified
- Feb 2021
- First submitted
- 2 Dec 2019
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities
- ClinicalTrials.gov ID
- NCT04186481
- Acronym / sponsor ID
- MINITAC / MINI.PMCF.2018.11
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Scapholunate Ligament Reconstructions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
Detailed description
Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minitac Ti 2.0 suture anchor | – | Device: MINITAC Ti 2.0 suture anchorSubjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
- Subject was ≥ 18 years of age at time of surgery.
- Subject status is > 12 months post-operative.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| MINITAC Ti 2.0 suture anchorThe MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand. | Device | Minitac Ti 2.0 suture anchor |
Primary outcome
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
Time frame: 6 months
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
1 secondary outcome
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc) principal investigator
Maitland Hand and Othopaedic surgery
Stephan Mangin study chair
Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew
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 Hallux Valgus Repairs and Medial or Lateral Instability Repairs/Reconstructions, run by Smith & Nephew, Inc. at 1 site in Australia.
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 1 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 26 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 1 site in Australia. 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 26 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 (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative (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 26 Feb 2021.