Safety and Performance of PEEK Anchors in Extremities

N/ACompletedNCT03782298

Smith & Nephew, Inc.140 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Medial or Lateral Instability Repairs/Reconstructions Hallux Valgus Repairs Achilles Tendon Repairs/Reconstructions Midfoot Reconstructions Metatarsal Ligament/Tendon Repairs/Reconstructions Bunionectomy Scapholunate Ligament Reconstructions Ulnar

Interventions

Spyromite, Dynomite, Raptomite, Footprint Ultra PK SLDEVICE

PEEK Suture Anchors, which include: * SPYROMITE™ 2.0 PK Suture Anchor with Needles * DYNOMITE™ 2.0 PK Suture Anchor with Needles * RAPTORMITE™ 3.0 Suture Anchor with Needles * FOOTPRINT™ Ultra PK SL Suture Anchor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

OrthoCarolina

Charlotte, North Carolina, United States

Precision Orthopaedic Specialties, Inc.

Chardon, Ohio, United States

Foot and Ankle Associates of North Texas-Grapevine

Grapevine, Texas, United States

Fowler Kennedy Sport Medicine Clinic

London, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

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