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Evaluating Foot and Ankle Products

This study is observing the continued safety and performance of several foot and ankle products from Arthrex. These include the ProStop® implant for hyperpronated foot (a condition where the foot rolls inward too much), Bio-Compression Screw for foot reconstruction, TRIM-IT Drill Pin® and TRIM-IT Spin Pin™ for fracture and fusion fixation, Headless Compression Screws and Compression FT Screws for small bone fragments, DynaNite® nitinol staple for midfoot/hindfoot fusions, BioComposite SutureTak® anchor for ankle stability, Beveled FT Screws for bunion repair, and KreuLock™ screws for ankle issues. The study aims to see how well these products work and if they are safe by tracking changes in your pain (Visual Analogue Scale), overall health (Veterans RAND Health survey), and foot/ankle abilities (Foot and Ankle Ability Measures survey) over time. You may be able to join if you are having surgery using one of these Arthrex products and are willing to complete questionnaires and attend follow-up visits. The study is currently observing up to 700 participants.

Study design
This is an observational study, meaning researchers will watch how the products perform in real-world use. It plans to enroll up to 700 participants.
What's involved
You would complete self-administered questionnaires before surgery and at 3, 6, and 12 months after surgery. You would also need to attend all study-related follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for at least 12 months after your surgery, with some assessments extending to two years for specific products.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04715139

Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Recruiting
Not specifiedAges 2+Observational
Arthrex, Inc.
~700 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Products listed in Group/Cohort Description

At a glance

Recruiting sites
3 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess change in Visual Analogue Scale (VAS) survey
Measured over preoperatively, 3 months, 6 months and 12 months post operative
+3 more outcomes measured

Conditions

Hyperpronated Foot
Reconstruction Surgeries of the Foot
Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle
Fixation of Small Bone Fragments of the Foot/Ankle
Lisfranc Arthrodesis
Mono or Bi-cortical Osteotomies in the Forefoot
First Metatarsophalangeal Arthrodesis
Akin Osteotomy
Midfoot and Hindfoot Arthrodeses or Osteotomies
Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)
Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus
Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)
Medial Ankle Stabilization
Tibiotalocalcaneal Arthrodesis

Explore related trials

Acquired hallux rigidusAnkle FractureBunionectomyFoot FractureFoot reconstructionHallux ValgusHyperpronated FootLisfranc ArthrodesisMedial Ankle InstabilityMetatarsus primus varusTibiotalocalcaneal arthrodesis

Where it's being run

7 sites across 7 states
California1
Illinois1
Tennessee1
Texas1
Virginia1
Germany1
South Africa1

Who to contact

Justin Moss, DHSc
[email protected]
770 584 4972
Email the study team

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What this trial measures

  • To assess change in Visual Analogue Scale (VAS) surveypreoperatively, 3 months, 6 months and 12 months post operative

    Patient reported pain scale 0-10 point scale (0 min, 10 max)

  • To assess changes in Veterans RAND Health (VR-12) surveypreoperatively, 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)

  • To assess changes in Foot and Ankle Ability Measures (FAAM) surveypreoperatively, 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

  • To assess change in Single Assessment Numeric Evaluation (SANE) surveypreoperatively, 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.