Medial or Lateral Instability Repairs/ReconstructionsNCT03782298

Safety and Performance of PEEK Anchors in Extremities

An observational study of Medial or Lateral Instability Repairs/Reconstructions and Hallux Valgus Repairs, run by Smith & Nephew, Inc. at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety and performance of the study devices in extremities up to 12 months post-surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions
What is being tested?: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
Type of treatment: Medical device
How many people: 140 participants
Where: 4 sitesin 2 countries
Study dates: 12 Mar 2019to 10 Oct 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: Subjects who have undergone extremity joint repair using the study devices, PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL)

Who may be able to join

Subjects who have undergone extremity joint repair using the study devices.
Subjects aged 18 years and older at the time of surgery.

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.
Subjects who are < 3 months post-operative

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

Precision Orthopaedic Specialties, Inc.
Chardon, Ohio, 44024
OrthoCarolina
Charlotte, North Carolina, 28207
Foot and Ankle Associates of North Texas-Grapevine
Grapevine, Texas, 76051

Other trials in United States

Canada1 site

Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7

Other trials in Canada

About this study

Official title: Safety and Performance of PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL) in Extremities

Safety and performance of the study devices in extremities up to 12 months post-surgery

Conditions: Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Bunionectomy
Being tested: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
Keywords: Dynomite, Spyromite, Raptormite, Foot, Ankle, Wrist, Hand, Elbow, Footprint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spyromite, Dynomite, Raptomite, Footprint Ultra PK SLDevice
PEEK Suture Anchors, which include:
- SPYROMITE™ 2.0 PK Suture Anchor with Needles
- DYNOMITE™ 2.0 PK Suture Anchor with Needles
- RAPTORMITE™ 3.0 Suture Anchor with Needles
- FOOTPRINT™ Ultra PK SL Suture Anchor

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention
Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
- no inflammatory or allergic response
- no device-related adverse event (AE)
- no device deficiencies (DDs) leading to revision surgery (re intervention) on the index extremity
Measured: 6 months

Secondary outcomes (1)

Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention
Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
- no inflammatory or allergic response
- no device-related adverse event (AE)
- no device deficiencies (DDs) leading to revision surgery (reintervention) on the index extremity
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 201910 Oct 2019

First posted20 Dec 2018
Study start12 Mar 2019
Primary completion10 Oct 2019
Study completion10 Oct 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 Medial or Lateral Instability Repairs/ReconstructionsStudies 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: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03782298
Sponsor's protocol ID: 2018.15.SMD.PEEK.RET.EXT
Status last verified: Nov 2021
First submitted: 6 Nov 2018
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Performance of PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL) in Extremities
ClinicalTrials.gov ID: NCT03782298
Acronym / sponsor ID: 2018.15.SMD.PEEK.RET.EXT
Conditions: Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Bunionectomy
Keywords: Dynomite, Spyromite, Raptormite, Foot, Ankle, Wrist, Hand, Elbow
Study type: Observational
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 12 Mar 2019 (actual)
Primary completion: 10 Oct 2019 (actual)
Study completion: 10 Oct 2019 (actual)
First posted: 20 Dec 2018 (actual)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Safety and performance of the study devices in extremities up to 12 months post-surgery

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who have undergone extremity joint repair using the study devices, PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL)

Key inclusion criteria (2 listed)

Subjects who have undergone extremity joint repair using the study devices.
Subjects aged 18 years and older at the time of surgery.

Key exclusion criteria (2 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.
Subjects who are < 3 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
Spyromite, Dynomite, Raptomite, Footprint Ultra PK SLPEEK Suture Anchors, which include: * SPYROMITE™ 2.0 PK Suture Anchor with Needles * DYNOMITE™ 2.0 PK Suture Anchor with Needles * RAPTORMITE™ 3.0 Suture Anchor with Needles * FOOTPRINT™ Ultra PK SL Suture Anchor	Device	–

Primary outcome

Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention
Time frame: 6 months
Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (re intervention) on the index extremity

1 secondary outcome

Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention
Time frame: 12 months

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Polyetheretherketone (PEEK) Extremity Suture Anchors	140	136

Primary outcome: Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Polyetheretherketone (PEEK) Extremity Suture Anchors n = 140
DYNOMITE™ 2.0 PK Suture Anchor with Needles: Yes	16
DYNOMITE™ 2.0 PK Suture Anchor with Needles: No	1
RAPTORMITE™ 3.0 PK Suture Anchor with Needles: Yes	70
RAPTORMITE™ 3.0 PK Suture Anchor with Needles: No	1
FOOTPRINT™ ULTRA PK SL SUTURE ANCHOR: Yes	57
FOOTPRINT™ ULTRA PK SL SUTURE ANCHOR: No	0

Population analysed: Participants analyzed at time frame specified for each row indicates participant provided retrospective data. Some participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on specific device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Surgery to End of Study (EOS) visit, approximately 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DYNOMITE™ 2.0 PK Suture Anchor With Needles	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
RAPTORMITE™ 3.0 Suture Anchor With Needles	2 of 71 (2.8%)	0 of 71 (0%)	0 of 71
FOOTPRINT™ Ultra PK SL Suture Anchor	2 of 57 (3.5%)	2 of 57 (3.5%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Judth Horner study chair

Smith & Nephew, Inc.

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Medial or Lateral Instability Repairs/Reconstructions and Hallux Valgus Repairs, run by Smith & Nephew, Inc. at 4 sites in 2 countries.

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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. 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 24 Sep 2024). 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?

Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03782298.

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 1 Oct 2024.