N/A
N=149
PMCF Study on PEEK Suture Anchors for Hip Indications
Soft Tissue to Bone Fixation
Bottom Line
View on ClinicalTrials.gov: NCT03814044 ↗Enrolled (actual)
149
Serious AEs
7.3%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention — 58; 0; 93; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PEEK Suture Anchors (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention |
58; 0; 93; 0 | — |
| SECONDARY Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention |
42; 0; 24; 0 | — |
| SECONDARY Visual Analog Scale (VAS) - Pain |
— | — |
| SECONDARY Count of Participants With Range of Motion (ROM) Full Functional Arc |
18; 10; 0; 8; 7; 0 | — |
| SECONDARY Range of Motion (ROM) |
97.5; 10.0; 37.5; 102.9; 35.0; 40.0 | — |
Summary
Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03814044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.