PMCF Study on PEEK Suture Anchors for Shoulder Indications

Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 464

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Grandview Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • OrthoArizona
  • Colorado
    • Denver, Colorado, United States, 80222
      • University of Colorado- Denver
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Holy Cross Hospital/Orthopedic Institute
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • OrthoAtlanta
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Community Hospital
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics Center
  • Texas
    • Baytown, Texas, United States, 77521
      • Houston Methodist at Baytown
    • Houston, Texas, United States, 77030
      • Texas Orthopedic Hospital - Houston
  • Wisconsin
    • New Berlin, Wisconsin, United States, 53151
      • Aspen Orthopedics at New Berlin
    • West Allis, Wisconsin, United States, 80222
      • Aspen Orthopedics at West Allis

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 received PEEK Suture Anchors implanted in the shoulder

Description

Inclusion Criteria:

1. Subjects who have undergone shoulder 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
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention	Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based 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 (re intervention) on the index shoulder	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention	Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based 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 (re intervention) on the index shoulder	12 months
Visual Analog Scale (VAS) - Pain	The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.	6 and 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 and 12 months
Range of Motion (ROM)	Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.	6 and 12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2019
• Primary Completion (ACTUAL): August 28, 2019
• Study Completion (ACTUAL): August 28, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): February 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: February 12, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2018.16.SMD.PEEK.RET.SHD

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