PMCF Study on PEEK Suture Anchors for Hip Indications

Completed

• Conditions: Soft Tissue to Bone Fixation

• Registration Number: NCT03814044
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-23
• Study Start: 2019-05-10
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Status Verified: 2023-09
• Results First Submitted: 2024-05-29
• Results First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Results First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

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

Exclusion Criteria

1. Subjects who are < 12 months post-operative.
2. 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
3. Subject had off-label use of the PEEK suture anchor during surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention	12 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
Visual Analog Scale (VAS) - Pain	6 and 12 months	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.
Count of Participants With Range of Motion (ROM) Full Functional Arc	6 months and 12 months	Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
Range of Motion (ROM)	6 and 12 months	Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care.

Trial Locations

Locations (4)

DMOS Orthopedic Centers; 🇺🇸 West Des Moines, Iowa, United States

Center for Advanced Orthopedic and Sports Medicine; 🇺🇸 Auburn Hills, Michigan, United States

Community Hospital - Oklahoma City; 🇺🇸 Oklahoma City, Oklahoma, United States

Southwest Orthopaedic Reconstructive Specialists; 🇺🇸 Oklahoma City, Oklahoma, United States