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Completed

NCT Number: NCT03782298

Safety and Performance of PEEK Anchors in Extremities

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

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fowler Kennedy Sport Medicine Clinic, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

Device

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

Primary outcomes

  1. Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention

    Time frame: 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 outcomes

  1. 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

    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

Other outcomes

  1. Visual Analog Scale (VAS) - Pain

    Time frame: 6 and 12 months

    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.

  2. Count of Participants With Range of Motion (ROM) Full Functional Arc

    Time frame: 6 and 12 months

    Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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