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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 6 to 7v11
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2027v10 Show 6 more changesShow less
    • Primary endpoints: 3 to 4
    • Enrollment target: 650 to 700
    • Study sites: 5 to 6
    • Study completion date: Dec 31, 2024 to Dec 31, 2027
    • Eligibility criteria expanded, about 250 words
    • Study description expanded, about 82 words
  3. Study sites revised (5)v9
  4. Site details revised at 1 of 5 sitesv8
  5. Study sites: 4 to 5v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 2 to 4v6
  2. Site details revised at 1 of 2 sitesv5
  3. Enrollment target: 50 to 650
    • Study sites: 1 to 2
    • Interventions: Arthrex ProStop Implant (Device) to Products listed in Group/Cohort Description (Device)
    • Eligibility criteria expanded, about 82 words
    v4
  4. Study title shortened, about 5 wordsv3
  5. Primary completion date: Dec 1, 2022 to Dec 1, 2024
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    • Study title expanded, about 12 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of the registry is to evaluate the continued safety and performance of 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® system and/or TRIM-IT Spin Pin™ system 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; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.
Trial Details
NCT Number NCT04715139
Lead Sponsor Arthrex, Inc.
Conditions
(from sponsor)		 Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle, Lisfranc Arthrodesis, Mono or Bi-cortical Osteotomies in the Forefoot, First Metatarsophalangeal Arthrodesis, Akin Osteotomy +6 more
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov