Soft Tissue to Bone FixationNCT03814044

PMCF Study on PEEK Suture Anchors for Hip Indications

An observational study of Soft Tissue to Bone Fixation, run by Smith & Nephew, Inc. at 4 sites in United States.

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

Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Soft Tissue to Bone Fixation
What is being tested?: PEEK Suture Anchors
Type of treatment: Medical device
How many people: 149 participants
Where: 4 sitesUnited States
Study dates: 10 May 2019to 10 Sep 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 hip joint repair using PEEK Suture Anchors: * BIORAPTOR Knotless Suture Anchors * SpeedLock Hip

Who may be able to join

Subjects who have undergone hip joint repair using the study devices.
Subjects aged 18 years and older at the time of surgery.
Subjects who had a visit to their provider between 3 and 15 months postoperative.

Who cannot join

Subjects who are < 12 months post-operative.
Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery
Subject had off-label use of the PEEK suture anchor during surgery.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Center for Advanced Orthopedic and Sports Medicine
Auburn Hills, Michigan, 48326
Community Hospital - Oklahoma City
Oklahoma City, Oklahoma, 73114
Southwest Orthopaedic Reconstructive Specialists
Oklahoma City, Oklahoma, 73139
DMOS Orthopedic Centers
West Des Moines, Iowa, 50266

Other trials in United States

About this study

Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.

Conditions: Soft Tissue to Bone Fixation
Being tested: PEEK Suture Anchors

What participants receive

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

PEEK Suture AnchorsDevice
Subjects who have undergone hip joint repair using PEEK Suture Anchors:
BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip 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 Hip Over a Time Period of 6 Months After Intervention
Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses 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 hip
Measured: 6 months

Secondary outcomes (4)

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention
Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses 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 hip
Measured: 12 months
Visual Analog Scale (VAS) - Pain
The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain and a score of 10 indicates extreme/unbearable pain. The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
Measured: 6 and 12 months
Count of Participants With Range of Motion (ROM) Full Functional Arc
Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
Measured: 6 months and 12 months
Range of Motion (ROM)
Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care.
Measured: 6 and 12 months

Timeline

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

10 May 201910 Sep 2019

First posted23 Jan 2019
Study start10 May 2019
Primary completion10 Sep 2019
Study completion10 Sep 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 Soft Tissue to Bone FixationStudies 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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03814044
Sponsor's protocol ID: 2018.14.SMD.PEEK.RET.HIP
Status last verified: Sep 2023
First submitted: 24 Oct 2018
Last updated: 15 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PMCF Study on PEEK Suture Anchors for Hip Indications
ClinicalTrials.gov ID: NCT03814044
Acronym / sponsor ID: 2018.14.SMD.PEEK.RET.HIP
Conditions: Soft Tissue to Bone Fixation
Study type: Observational
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 10 May 2019 (actual)
Primary completion: 10 Sep 2019 (actual)
Study completion: 10 Sep 2019 (actual)
First posted: 23 Jan 2019 (actual)
Results: Posted 15 Oct 2024

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 (PMCF) on the PEEK Suture Anchors in the hip.

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 hip joint repair using PEEK Suture Anchors: * BIORAPTOR Knotless Suture Anchors * SpeedLock Hip

Key inclusion criteria (3 listed)

Subjects who have undergone hip joint repair using the study devices.
Subjects aged 18 years and older at the time of surgery.
Subjects who had a visit to their provider between 3 and 15 months postoperative.

Key exclusion criteria (3 listed)

Subjects who are < 12 months post-operative.
Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery
Subject had off-label use of the PEEK suture anchor during surgery.

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
PEEK Suture AnchorsSubjects who have undergone hip joint repair using PEEK Suture Anchors: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor	Device	–

Primary outcome

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention
Time frame: 6 months
Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses 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 hip

4 secondary outcomes

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention
Time frame: 12 months
Visual Analog Scale (VAS) - Pain
Time frame: 6 and 12 months
Count of Participants With Range of Motion (ROM) Full Functional Arc
Time frame: 6 months and 12 months
Range of Motion (ROM)
Time frame: 6 and 12 months

Results and safety

Results posted to the registry on 15 Oct 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) Hip Suture Anchors	149	148

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

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

Measure	Polyetheretherketone (PEEK) Hip Suture Anchors n = 149
BIORAPTOR™ Knotless Suture Anchor: Yes	58
BIORAPTOR™ Knotless Suture Anchor: No	0
SpeedLock Hip Suture Anchor: Yes	93
SpeedLock Hip Suture Anchor: No	0

Population analysed: Participants analyzed for each row indicate those with available retrospective data for the time frame \& outcome specified. 2 participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on 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.

4 secondary outcomes are 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
BIORAPTOR™ Knotless Suture Anchor	5 of 58 (8.6%)	1 of 58 (1.7%)	0 of 58
SpeedLock Hip Suture Anchor	6 of 93 (6.5%)	11 of 93 (11.8%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 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.

Judith Horner study chair

Smith & Nephew, Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Soft Tissue to Bone Fixation, run by Smith & Nephew, Inc. at 4 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 3 inclusion and 3 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 15 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. 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 15 Oct 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 Hip 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 NCT03814044.

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 15 Oct 2024.