for people ages 2 years and up (full criteria)
Healthy Volunteers
healthy people welcome
at UC Davis
study started
completion around
Principal Investigator
by Christopher Kreulen, MD (ucdavis)



The objective of the registry is to evaluate the continued safety and performance of the 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, TRIM-IT Spin Pin 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 and DynaNite® Nitinol Staple to be used for fixation such as 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), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus and Beveled Headed FT Screws for osteotomy fixation of Hallux valgus repair (such as Scarf and Chevron etc.)

Official Title

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products


To assess safety, related adverse events will be evaluated at six months postoperative and at one-year postoperative time points. To evaluate performance, physical exam and imaging of the target area of the body will be evaluated at three months postoperative. Additionally, patient reported outcomes will be evaluated at three months postoperative, six months postoperative and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12) and Foot and Ankle Ability Measures (FAAM).


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.), Hallux Valgus, Bunion, Hallux Varus, Products listed in Group/Cohort Description, All Products listed in Descriptions


You can join if…

Open to people ages 2 years and up

  1. Subject requires surgery for treatment of hyperpronated foot using the Arthrex ProStop® implant
  2. Subject is 18 years of age or over (all products except ProStop)
  3. Subject age >two to 17 years (ProStop product only)
  4. Subject is not pregnant, nursing, prisoner, or ward of the state
  5. Subject or subject's representative signed informed consent and assent when, applicable, and is willing and able to comply with all study requirements

You CAN'T join if...

  1. Insufficient quantity or quality of bone
  2. Blood supply limitations and previous infections, which may retard healing
  3. Foreign-body sensitivity
  4. Any active infection or blood supply limitations
  5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period
  6. Subjects that are skeletally immature (except for ProStop)

    (DynaNite Nitinol Staple Subjects ONLY)

  7. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite Nitinol Staples directions for use
  8. Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite Nitinol Staples directions for use


  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Barrett Podiatry terminated
    San Antonio Texas 78258 United States
  • TOA Research Foundation accepting new patients
    Nashville Tennessee 37209 United States

Lead Scientist at University of California Health

  • Christopher Kreulen, MD (ucdavis)
    Associate Professor, Orthopaedic Surgery, School of Medicine. Authored (or co-authored) 41 research publications


accepting new patients
Start Date
Completion Date
Arthrex, Inc.
Study Type
Observational [Patient Registry]
Expecting 650 study participants
Last Updated