Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in Extremities

Completed

• Conditions: Bunionectomy; Lateral Epicondylitis Repair; Hallux Valgus Repairs; Metatarsal Ligament/Tendon Repairs/Reconstructions; Scapholunate Ligament Reconstructions; Medial or Lateral Instability Repairs/Reconstructions; Ulnar; Achilles Tendon Repairs/Reconstructions; Midfoot Reconstructions; Bicep Tendon Reattachments

• Registration Number: NCT03782298
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

Safety and performance of the study devices in extremities over a time period of 6 months after intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-03-12
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Status Verified: 2021-11
• Results First Submitted: 2023-09-19
• Results First Submitted QC: 2024-09-18
• Results First Posted: 2024-09-24
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & 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 Extremity Over a Time Period of 6 Months After Intervention	6 months	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention	12 months	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

Trial Locations

Locations (4)

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States

Precision Orthopaedic Specialties, Inc.; 🇺🇸 Chardon, Ohio, United States

Fowler Kennedy Sport Medicine Clinic; 🇨🇦 London, Ontario, Canada

Foot and Ankle Associates of North Texas-Grapevine; 🇺🇸 Grapevine, Texas, United States