A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
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.
• 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.
• (ArthroFLEX® subjects only):
• Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.
• Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.
• DualCompression Hindfoot Nail subjects only:
• The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.
⁃ The participant should be undergoing treatment with the Arthrex DualCompression Hindfoot Nail, either as a primary procedure or as a revision surgery, per standard of care