PMCF Study on PEEK Suture Anchors for Hip Indications

Post-market clinical follow-up 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): 162

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
• Genders Eligible for Study: All

• 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.

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success of the study devices in hip over a time period of 6 months after intervention	Clinical success is defined as the number of device failures in the hip	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success of the study devices in hip over a time period of 12 months after intervention	Clinical success is defined as the number of device failures in the hip	12 months
Visual Analog Scale (VAS) - pain	0 to 10 is the scoring range of pain for the joint that received treatment with the anchor	12 months
Range of Motion (ROM)	Flexion, extension, abduction, adduction, external/internal rotation will be captured in degrees based on physican's Standard of Care for this retrospective study.	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): April 23, 2019
• Primary Completion (ACTUAL): August 15, 2019
• Study Completion (ACTUAL): August 15, 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): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

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