RecruitingNCT04715139

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

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products


Sponsor

Arthrex, Inc.

Enrollment

700 participants

Start Date

Dec 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is a registry tracking the safety and long-term performance of Arthrex foot and ankle surgical products, including various implants and devices used in ankle fusion, big toe joint replacement, and other foot and ankle procedures. Registries like this are important for gathering real-world data on how medical devices perform outside of tightly controlled clinical trials. Participants will be followed through their normal clinical care, completing questionnaires about their symptoms and function at various time points after surgery. The goal is to build a comprehensive dataset that helps surgeons and device manufacturers improve future care. You may be eligible if... - You are 18 years of age or older (or 2–17 years for a specific product called ProStop) - You need surgery using one of the Arthrex foot and ankle products covered by the registry - You are able to complete questionnaires and return for follow-up visits You may NOT be eligible if... - You have insufficient bone quality or an active infection in the surgical area - You are currently pregnant - You are a prisoner or other vulnerable individual - You are already receiving workers' compensation benefits for the same condition - You have another planned surgery on the same or opposite lower limb during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEProducts listed in Group/Cohort Description

Depending on approved indication per product


Locations(7)

UC Davis Medical Center

Sacramento, California, United States

Northwestern University

Chicago, Illinois, United States

TOA Research Foundation

Nashville, Tennessee, United States

Barrett Podiatry

San Antonio, Texas, United States

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, United States

OrthoPedes

Duisburg, Germany

Dr Haroun Mahomed Orthopaedic Practice

Durban, South Africa

View Full Details on ClinicalTrials.gov

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NCT04715139