PMCF Study on PEEK Suture Anchors for Hip Indications

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

Study Overview

• Status: Completed
• Conditions: Soft Tissue to Bone Fixation
• Intervention / Treatment: Device: PEEK Suture Anchors

• Study Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• United States
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • DMOS Orthopedic Centers
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Center for Advanced Orthopedic and Sports Medicine
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Community Hospital - Oklahoma City
    • Oklahoma City, Oklahoma, United States, 73139
      • Southwest Orthopaedic Reconstructive Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have undergone hip joint repair using PEEK Suture Anchors:

• BIORAPTOR Knotless Suture Anchors
• SpeedLock Hip

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) - Pain	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.	6 and 12 months
Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention	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	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.	6 months and 12 months
Range of Motion (ROM)	Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care.	6 and 12 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Judith Horner, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): September 10, 2019

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018.14.SMD.PEEK.RET.HIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No