N/A N=464

PMCF Study on PEEK Suture Anchors for Shoulder Indications

Soft Tissue to Bone Fixation

Bottom Line

View on ClinicalTrials.gov: NCT03826667 ↗

Enrolled (actual)

464

Serious AEs

8.6%

Results posted

Apr 2022

Primary outcome: Primary: Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention — 185; 6; 38; 3 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Polyetheretherketone (PEEK) Shoulder Suture Anchors (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Smith & Nephew, Inc.
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention	185; 6; 38; 3; 71; 6	—
SECONDARY Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention	50; 1; 5; 0; 17; 1	—
SECONDARY Visual Analog Scale (VAS) - Pain	1.8; 2.4; 2.5; 4.5; 2.2; 2.3	—
SECONDARY Count of Participants With Range of Motion (ROM) Full Functional Arc	111; 48; 4; 37; 10; 2	—
SECONDARY Range of Motion (ROM)	157; 25.7; 49.3; 141.1; 75; 59.4	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03826667). 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.