Products listed in Group/Cohort Description
DeviceDepending on approved indication per product
NCT Number: NCT04715139
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.
Interested in participating?
Request Info2 year and older
All sexes
Observational
OrthoPedes, Duisburg, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(ArthroFLEX® subjects only):
DualCompression Hindfoot Nail subjects only:
Exclusion criteria
(® Nitinol Staple Subjects only):
(ArthroFLEX® subjects only):
(DualCompression Hindfoot Nail subjects only):
Depending on approved indication per product
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported pain scale 0-10 point scale (0 min, 10 max)
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
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
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
Patient reported change to affected body part on a scale from 0 to 100, with 100 representing their normal function.
Contact information is provided by the study sponsor or research team.
Arthrex, Inc.
Industry
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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