Safety and Performance of PEEK Anchors in Extremities

Safety and Performance of PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL) in Extremities

Safety and performance of the study devices in extremities up to 12 months post-surgery

Study Overview

• Status: Completed
• Conditions: Bunionectomy; Hallux Valgus Repairs; Medial or Lateral Instability Repairs/Reconstructions; Achilles Tendon Repairs/Reconstructions; Midfoot Reconstructions; Metatarsal Ligament/Tendon Repairs/Reconstructions; Scapholunate Ligament Reconstructions; Lateral Epicondylitis Repair; Ulnar; Bicep Tendon Reattachments
• Intervention / Treatment: Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Fowler Kennedy Sport Medicine Clinic
• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
  • Ohio
    • Chardon, Ohio, United States, 44024
      • Precision Orthopaedic Specialties, Inc.
  • Texas
    • Grapevine, Texas, United States, 76051
      • Foot and Ankle Associates of North Texas-Grapevine

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 extremity joint repair using the study devices, PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
• Subjects who are < 3 months post-operative

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 Extremity Over a Time Period of 6 Months After Intervention	Clinical success was defined as extremity 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 extremity	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention	Clinical success was defined as extremity 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 (reintervention) on the index extremity	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Hand; Elbow; Ankle; Foot; Wrist; Dynomite; Spyromite; Raptormite; Footprint
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Foot Deformities; Elbow Injuries; Tennis Elbow; Hallux Valgus
• Other Study ID Numbers: 2018.15.SMD.PEEK.RET.EXT

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