Soft Tissue to Bone FixationNCT03826667

PMCF Study on PEEK Suture Anchors for Shoulder Indications

An observational study of Soft Tissue to Bone Fixation, run by Smith & Nephew, Inc. at 11 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 on the PEEK Suture Anchors in the shoulder. 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?: Polyetheretherketone (PEEK) Shoulder Suture Anchors
Type of treatment: Medical device
How many people: 464 participants
Where: 11 sitesUnited States
Study dates: 14 Feb 2019to 28 Aug 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 received PEEK Suture Anchors implanted in the shoulder

Who may be able to join

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

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

University Orthopedics Center
Altoona, Pennsylvania, 16602
Houston Methodist at Baytown
Baytown, Texas, 77521
Grandview Medical Center
Birmingham, Alabama, 35242
University of Colorado- Denver
Denver, Colorado, 80222
Holy Cross Hospital/Orthopedic Institute
Fort Lauderdale, Florida, 33334
Texas Orthopedic Hospital - Houston
Houston, Texas, 77030
OrthoAtlanta
Lawrenceville, Georgia, 30046
Aspen Orthopedics at New Berlin
New Berlin, Wisconsin, 53151
Community Hospital
Oklahoma City, Oklahoma, 73114
OrthoArizona
Phoenix, Arizona, 85018
Aspen Orthopedics at West Allis
West Allis, Wisconsin, 80222

Other trials in United States

About this study

Official title: Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications

Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.

Conditions: Soft Tissue to Bone Fixation
Being tested: Polyetheretherketone (PEEK) Shoulder Suture Anchors

What participants receive

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

Polyetheretherketone (PEEK) Shoulder Suture AnchorsDevice
PEEK Suture Anchors, which include:
- HEALICOIL™ PK Preloaded Suture Anchors
- BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
- BIORAPTOR™ Knotless Suture Anchors
- MULTIFIX™ S Ultra Knotless Fixation System
- FOOTPRINT™ Ultra PK Suture Anchors
- TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
- SPEEDSCREW™ Knotless Fixation System
- SpeedLock Knotless Fixation Device

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 Shoulder Over a Time Period of 6 Months After Intervention
Clinical success was defined as shoulder 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 shoulder
Measured: 6 months

Secondary outcomes (4)

Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
Clinical success was defined as shoulder 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 shoulder
Measured: 12 months
Visual Analog Scale (VAS) - Pain
The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). 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 and 12 months
Range of Motion (ROM)
Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on 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.

14 Feb 201928 Aug 2019

First posted1 Feb 2019
Study start14 Feb 2019
Primary completion28 Aug 2019
Study completion28 Aug 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.
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: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03826667
Sponsor's protocol ID: 2018.16.SMD.PEEK.RET.SHD
Status last verified: Feb 2022
First submitted: 30 Jan 2019
Last updated: 12 Apr 2022
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 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications
ClinicalTrials.gov ID: NCT03826667
Acronym / sponsor ID: 2018.16.SMD.PEEK.RET.SHD
Conditions: Soft Tissue to Bone Fixation
Study type: Observational
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 14 Feb 2019 (actual)
Primary completion: 28 Aug 2019 (actual)
Study completion: 28 Aug 2019 (actual)
First posted: 1 Feb 2019 (actual)
Results: Posted 12 Apr 2022

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 on the PEEK Suture Anchors in the shoulder.

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 received PEEK Suture Anchors implanted in the shoulder

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 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.

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
Polyetheretherketone (PEEK) Shoulder Suture AnchorsPEEK Suture Anchors, which include: * HEALICOIL™ PK Preloaded Suture Anchors * BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors * BIORAPTOR™ Knotless Suture Anchors * MULTIFIX™ S Ultra Knotless Fixation System * FOOTPRINT™ Ultra PK Suture Anchors * TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles * SPEEDSCREW™ Knotless Fixation System * SpeedLock Knotless Fixation Device	Device	–

Primary outcome

Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
Time frame: 6 months
Clinical success was defined as shoulder 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 shoulder

4 secondary outcomes

Number of Participants With Clinical Success of the Study Devices in the Shoulder 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 and 12 months
Range of Motion (ROM)
Time frame: 6 and 12 months

Results and safety

Results posted to the registry on 12 Apr 2022, 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) Shoulder Suture Anchors	464	443

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

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

Measure	Polyetheretherketone (PEEK) Shoulder Suture Anchors n = 458
HEALICOIL™ PK Preloaded Suture Anchors: Yes	185
HEALICOIL™ PK Preloaded Suture Anchors: No	6
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: Yes	38
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: No	3
MULTIFIX™ S Ultra Knotless Fixation System: Yes	71
MULTIFIX™ S Ultra Knotless Fixation System: No	6
FOOTPRINT™ Ultra PK Suture Anchor: Yes	128
FOOTPRINT™ Ultra PK Suture Anchor: No	3

Population analysed: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates 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
HEALICOIL™ PK Preloaded Suture Anchors	15 of 193 (7.8%)	40 of 193 (20.7%)	0 of 193
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors	7 of 41 (17.1%)	27 of 41 (65.9%)	0 of 41
MULTIFIX™ S Ultra Knotless Fixation System	13 of 78 (16.7%)	38 of 78 (48.7%)	0 of 78
FOOTPRINT™ Ultra PK Suture Anchors	10 of 136 (7.4%)	24 of 136 (17.6%)	0 of 136
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles	1 of 57 (1.8%)	5 of 57 (8.8%)	0 of 57
SPEEDSCREW™ Knotless Fixation System	4 of 59 (6.8%)	4 of 59 (6.8%)	0 of 59
SpeedLock Knotless Fixation Device	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): No limitations reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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.

11 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 11 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 12 Apr 2022). 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 Shoulder 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 NCT03826667.

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 12 Apr 2022.