N/A
Completed N=140
Safety and Performance of PEEK Anchors in Extremities
Medial or Lateral Instability Repairs/Reconstructions · Hallux Valgus Repairs · Achilles Tendon Repairs/Reconstructions · Midfoot Reconstructions
Source: ClinicalTrials.gov NCT03782298 ↗
Enrolled (actual)
140
Serious AEs
2.8%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention — 16; 1; 70; 1 Participants
Summary
Safety and performance of the study devices in extremities up to 12 months post-surgery
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention |
16; 1; 70; 1; 57; 0 | — |
| SECONDARY Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention |
2; 0; 8; 0; 16; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have undergone extremity joint repair using the study devices.
- Subjects aged 18 years and older at the time of surgery.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03782298). 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. Informational only — not medical advice.