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.
Device-related adverse events will be continuously assessed and summarized at three months, six months, one year, and two years postoperatively to evaluate safety. A physical exam of the target area will be conducted three months postoperatively to evaluate performance. Range of motion (ROM) will be assessed preoperatively, at three months, six months, and one year postoperatively for the ArthroFLEX® dermal allograft only. Patient-reported outcomes (PROs) will be evaluated for all products at three months, six months, and one year. Additionally, PROs will be assessed at two years postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only. PROs include the Foot and Ankle Ability Measures (FAAM), Visual Analogue Scale (VAS), Single Assessment Numeric Evaluation (SANE) score, and Veterans Rand 12-Item Health Survey (VR-12). DualCompression X-rays will be evaluated at six months and one year postoperatively for ArthroFLEX® dermal allograft and DualCompression Hindfoot Nail only, and CT scans will be assessed at three months postoperatively for DualCompression Hindfoot Nail only.
Study Type
OBSERVATIONAL
Enrollment
700
Depending on approved indication per product
UC Davis Medical Center
Sacramento, California, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGTOA Research Foundation
Nashville, Tennessee, United States
TERMINATEDBarrett Podiatry
San Antonio, Texas, United States
TERMINATEDAtlantic Orthopaedic Specialists
Virginia Beach, Virginia, United States
RECRUITINGOrthoPedes
Duisburg, Germany
TERMINATEDDr Haroun Mahomed Orthopaedic Practice
Durban, South Africa
TERMINATEDTo assess change in Visual Analogue Scale (VAS) survey
Patient reported pain scale 0-10 point scale (0 min, 10 max)
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
To assess changes in Veterans RAND Health (VR-12) survey
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
To assess changes in Foot and Ankle Ability Measures (FAAM) survey
Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
To assess change in Single Assessment Numeric Evaluation (SANE) survey
Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
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