Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
NCT04715139 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Products listed in Group/Cohort Description
Study Locations (7)
Other
- OrthoPedes — Duisburg
- Dr Haroun Mahomed Orthopaedic Practice — Durban
California
- UC Davis Medical Center — Sacramento
Illinois
- Northwestern University — Chicago
Tennessee
- TOA Research Foundation — Nashville
Texas
- Barrett Podiatry — San Antonio
Virginia
- Atlantic Orthopaedic Specialists — Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2027-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04715139
The ClinicalTrials.gov registry entry for NCT04715139 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arthrex, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Hyperpronated Foot appearing as the primary indexed condition, and to 1 intervention — of which Products listed in Group/Cohort Description is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04715139 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04715139 about?
NCT04715139 is a clinical study titled "Evaluate the Continued Safety and Performance of the Foot and Ankle Products". 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 f...
What is the current status of trial NCT04715139?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2020-12-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04715139 study?
This clinical trial studies the following conditions: 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04715139?
The interventions under investigation include: Products listed in Group/Cohort Description (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04715139?
This trial is sponsored by Arthrex, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04715139 being conducted?
This trial has 7 study locations across California, Illinois, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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