Evaluate the Continued Safety and Performance of the Foot and Ankle Products (NCT04715139) | Clinical Trial Compass
RecruitingNot Applicable
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
United States, Germany, South Africa700 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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®).
. Subject age \>two to 17 years (ProStop® 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess change in Visual Analogue Scale (VAS) survey
Timeframe: preoperatively, 3 months, 6 months and 12 months post operative
2
To assess changes in Veterans RAND Health (VR-12) survey
Timeframe: preoperatively, 3 months, 6 months and 12 months post operative
3
To assess changes in Foot and Ankle Ability Measures (FAAM) survey
Timeframe: preoperatively, 3 months, 6 months and 12 months post operative
4
To assess change in Single Assessment Numeric Evaluation (SANE) survey
Timeframe: preoperatively, 3 months, 6 months and 12 months post operative