Actively Recruiting
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Led by Arthrex, Inc. · Updated on 2026-02-11
700
Participants Needed
7
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject requires surgery using Arthrex foot and ankle products included in the registry.
- Subject is 18 years of age or over (all products except ProStop�ae).
- Subject age greater than two to 17 years (ProStop�ae product only).
- Capable of completing self-administered questionnaires.
- Willing and able to return for all study-related follow-up visits.
- Subject or subject's representative signed informed consent and assent, when applicable, and is willing and able to comply with all study requirements.
- Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4 (ArthroFLEX�ae subjects only).
- Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP (ArthroFLEX�ae subjects only).
- Participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis (DualCompression Hindfoot Nail subjects only).
- Participant undergoing treatment with Arthrex DualCompression Hindfoot Nail as primary or revision surgery per standard of care (DualCompression Hindfoot Nail subjects only).
You will not qualify if you...
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections that may retard healing.
- Foreign-body sensitivity.
- Any active infection or blood supply limitations.
- Conditions limiting ability or willingness to restrict activities or follow directions during healing.
- Subjects that are skeletally immature (except for ProStop�ae).
- Subject is considered from vulnerable population (child, prisoner, pregnant).
- Subjects contraindicated for these devices.
- Subject currently receiving compensation or benefits due to a work-related injury or illness.
- Subject has planned or scheduled additional surgery on affected or contralateral lower extremity during study.
- Subjects with comminuted bone surface preventing staple placement (Nitinol Staple subjects only).
- Subjects with pathological bone conditions impairing implant fixation (Nitinol Staple subjects only).
- Additional ipsilateral lower limb pathology requiring active treatment (ArthroFLEX�ae subjects only).
- Bilateral degenerative or post-traumatic arthritis of 1st MTP joints requiring simultaneous treatment (ArthroFLEX�ae subjects only).
- Diagnosis of gout (ArthroFLEX�ae subjects only).
- Significant bone loss, avascular necrosis, or large osteochondral cyst (>1cm) of 1st MTP joint (ArthroFLEX�ae subjects only).
- Lesions greater than 10mm in size (ArthroFLEX�ae subjects only).
- Hallux varus of any degree or hallux valgus >20 degrees (ArthroFLEX�ae subjects only).
- Requiring only tibiotalar or subtalar arthrodesis (DualCompression Hindfoot Nail subjects only).
- Patient requires bulk allograft or metal spacer implant for large bone defect and limb salvage (DualCompression Hindfoot Nail subjects only).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
TOA Research Foundation
Nashville, Tennessee, United States, 37209
Terminated
4
Barrett Podiatry
San Antonio, Texas, United States, 78258
Terminated
5
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
6
OrthoPedes
Duisburg, Germany, 47169
Terminated
7
Dr Haroun Mahomed Orthopaedic Practice
Durban, South Africa, 3629
Terminated
Research Team
J
Justin Moss, DHSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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