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NCT04715139 · ClinicalTrials.gov registry record
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
A clinical trial of Hyperpronated Foot and Reconstruction Surgeries of the Foot, sponsored by Arthrex.
- Recruiting
- Registry status
- 700
- Enrollment target
- 7
- Study locations
NCT04715139: Recruiting study of Hyperpronated Foot and Reconstruction Surgeries of the Foot, sponsored by Arthrex.
NCT04715139 is a study of Hyperpronated Foot and Reconstruction Surgeries of the Foot that is actively recruiting participants, run by Arthrex. The registered enrollment target is 700 participants. The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04715139, a study of Hyperpronated Foot and Reconstruction Surgeries of the Foot, is actively recruiting participants, sponsored by Arthrex.
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Patient reported pain scale 0-10 point scale (0 min, 10 max)
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 |
What NCT04715139 shows while recruiting
NCT04715139 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT04715139 lists 7 locations in 6 states (Other, California, Illinois).
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.
What interventions are being tested in trial NCT04715139?
The interventions under investigation include: Products listed in Group/Cohort Description (DEVICE).
Who is sponsoring clinical trial NCT04715139?
This trial is sponsored by Arthrex, which has 12 total clinical trials registered on ClinicalTrials.gov.
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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