Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Last updated: June 26, 2023
Sponsor: Arthrex, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bunion

Treatment

Products listed in Group/Cohort Description

Clinical Study ID

NCT04715139
AIRR-0006
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of the registry is to evaluate the continued safety and performance of the Arthrex foot and ankle products including the ProStop implant for hyperpronated foot, Bio-Compression Screw for reconstruction surgeries of the foot, TRIM-IT Drill Pin, TRIM-IT Spin Pin for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle, Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle and DynaNite® Nitinol Staple to be used for fixation such as Lisfranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus and Beveled Headed FT Screws for osteotomy fixation of Hallux valgus repair (such as Scarf and Chevron etc.)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject requires surgery for treatment of hyperpronated foot using the ArthrexProStop® implant
  2. Subject is 18 years of age or over (all products except ProStop)
  3. Subject age >two to 17 years (ProStop product only)
  4. Subject is not pregnant, nursing, prisoner, or ward of the state
  5. Subject or subject's representative signed informed consent and assent when,applicable, and is willing and able to comply with all study requirements

Exclusion

Exclusion Criteria:

  1. Insufficient quantity or quality of bone
  2. Blood supply limitations and previous infections, which may retard healing
  3. Foreign-body sensitivity
  4. Any active infection or blood supply limitations
  5. Conditions that tend to limit the patient's ability or willingness to restrictactivities or follow directions during the healing period
  6. Subjects that are skeletally immature (except for ProStop) (DynaNite Nitinol Staple Subjects ONLY)
  7. Subjects who have a comminuted bone surface that would not allow for staple placementas required by the DynaNite Nitinol Staples directions for use
  8. Subjects who have pathologic bone conditions such as osteopenia that would impair theability to securely fix the implant as required by the DynaNite Nitinol Staplesdirections for use

Study Design

Total Participants: 650
Treatment Group(s): 1
Primary Treatment: Products listed in Group/Cohort Description
Phase:
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2024

Study Description

To assess safety, related adverse events will be evaluated at six months postoperative and at one-year postoperative time points. To evaluate performance, physical exam and imaging of the target area of the body will be evaluated at three months postoperative. Additionally, patient reported outcomes will be evaluated at three months postoperative, six months postoperative and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12) and Foot and Ankle Ability Measures (FAAM).

Connect with a study center

  • OrthoPedes

    Duisburg, 47169
    Germany

    Active - Recruiting

  • Dr Haroun Mahomed Orthopaedic Practice

    Durban, 3629
    South Africa

    Active - Recruiting

  • Life Westville Hospital

    Durban, 3629
    South Africa

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • TOA Research Foundation

    Nashville, Tennessee 37209
    United States

    Active - Recruiting

  • Barrett Podiatry

    San Antonio, Texas 78258
    United States

    Terminated

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.