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 States700 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 range2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. 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).
âś“. Capable of completing self-administered questionnaires.
âś“. Willing and able to return for all study-related follow-up visits.
âś“. Subject or subject's representative signed informed consent and assent, when applicable, and is willing and able to comply with all study requirements.
âś“. Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.
âś“. Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.
Exclusion criteria
âś•. Insufficient quantity or quality of bone.
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