Actively Recruiting
A Multi-Center, Prospective Registry to 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are monitoring the ongoing safety and performance of various Arthrex foot and ankle medical devices. These include implants and screws for treating hyperpronated foot, reconstructive surgeries, fracture fixation, arthrodeses, osteotomies, and joint stabilization. The study also evaluates devices like the ArthroFLEX dermal allograft and the DualCompression Hindfoot Nail for specific foot and ankle conditions. This registry collects data from patients undergoing procedures with these products to better understand their outcomes. The devices studied include the ProStop implant, Bio-Compression Screw, TRIM-IT Drill and Spin Pin systems, Headless and Compression FT Screws, DynaNite nitinol staple, BioComposite SutureTak anchor, Beveled FT Screws, KreuLock screws, ArthroFLEX dermal allograft, and DualCompression Hindfoot Nail. Patients receive surgical treatments using these products as indicated. The study tracks device-related adverse events at 3, 6, 12, and 24 months after surgery to assess safety. Performance is evaluated through physical exams and range of motion measurements, particularly for the ArthroFLEX allograft. Participants complete patient-reported outcome surveys including the Foot and Ankle Ability Measures, Visual Analogue Scale, Single Assessment Numeric Evaluation, and Veterans Rand 12-Item Health Survey at various times up to two years post-surgery. Imaging such as X-rays and CT scans are used to monitor specific devices at set intervals. The study requires follow-up visits to assess recovery, device function, and safety. Participation may last for at least two years after surgery, with scheduled assessments throughout this period.
CONDITIONS
Brief 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 for all products except ProStop�ae.
- Subject age is between 2 and 17 years for 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.
- (ArthroFLEX�ae subjects only): Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.
- (ArthroFLEX�ae subjects only): Require surgical intervention or medically indicated for arthrodesis or arthroplasty of the 1st MTP.
- (DualCompression Hindfoot Nail subjects only): Have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis.
- (DualCompression Hindfoot Nail subjects only): Undergoing treatment with the Arthrex DualCompression Hindfoot Nail as a primary or revision surgery per standard care.
You will not qualify if you...
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections that may delay healing.
- Foreign-body sensitivity.
- Any active infection or blood supply limitations.
- Conditions limiting ability or willingness to restrict activities during healing.
- Subjects who are skeletally immature except for ProStop�ae.
- Considered part of a vulnerable population (child, prisoner, pregnant).
- Contraindicated for these devices.
- Currently receiving compensation or benefits due to work-related injury or illness.
- Planned or scheduled additional surgery on affected or opposite lower extremity during the study.
- (DynaNite�ae Nitinol Staple subjects only): Comminuted bone surface preventing staple placement.
- (DynaNite�ae Nitinol Staple subjects only): Pathologic bone conditions like osteopenia impairing implant fixation.
- (ArthroFLEX�ae subjects only): Additional ipsilateral lower limb pathology needing 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) in 1st MTP joint.
- (ArthroFLEX�ae subjects only): Lesions larger than 10mm.
- (ArthroFLEX�ae subjects only): Hallux varus of any degree or hallux valgus >20 degrees.
- (DualCompression Hindfoot Nail subjects only): Only require tibiotalar or subtalar arthrodesis.
- (DualCompression Hindfoot Nail subjects only): Need bulk allograft or metal spacer to fill large bone defect for limb salvage.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery using Arthrex foot and ankle products as part of their treatment.
1 visit (in-person)
Duration - Up to 2 years postoperatively
Participants have follow-up assessments including physical exams, range of motion evaluations, imaging, and patient-reported outcomes to monitor safety and performance of the devices.
Visits at 3 months, 6 months, 1 year, and 2 years postoperatively depending on the device
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
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
Frequently Asked Questions
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