Recruiting

Foot and Ankle Products

Sponsor:

Arthrex, Inc.

Code:

NCT04715139

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

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Products listed in Group/Cohort Description

Study Details

Brief summary:

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.

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

Study ID

NCT04715139

Start date

Dec 1, 2020

Status verified date

Jun, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Subject requires surgery using Arthrex foot and ankle products included in the registry.
2. Subject is 18 years of age or over (all products except ProStop®).
3. Subject age >two to 17 years (ProStop® product only).
4. Capable of completing self-administered questionnaires.
5. Willing and able to return for all study-related follow-up visits.
6. 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):
7. Degenerative or post-traumatic arthritis of the 1st MTP joint with grade 2, 3, or 4.
8. Subjects who require surgical intervention or are medically indicated for an arthrodesis or arthroplasty of the 1st MTP.

DualCompression Hindfoot Nail subjects only:
9. The participant must have instability, arthritis, rigid deformity, or severe foot or ankle deformity necessitating tibiotalocalcaneal arthrodesis, commonly referred to as TTC arthrodesis.
10. 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

Exclusion Criteria:

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®).
7. Subject is considered from vulnerable population (i.e., child, prisoner, pregnant).
8. Subjects who are contraindicated for these devices.
9. Subject is currently receiving compensation or benefits due to a work-related injury or illness under any applicable occupational injury or disability program.
10. Subject has a planned or scheduled additional surgery on the affected or contralateral lower extremity within the course of the study.

(® Nitinol Staple Subjects only):
11. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite® Nitinol Staples directions for use.
12. 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.

(ArthroFLEX® subjects only):
13. Additional ipsilateral lower limb pathology that requires active treatment.
14. Bilateral degenerative or post-traumatic arthritis of the 1st MTP joints that would require simultaneous treatment of both MTP joints.
15. Diagnosis of gout.
16. Any significant bone loss, avascular necrosis, and/or large osteochondral cyst (>1cm) of the 1st MTP joint.
17. Lesions greater than 10mm in size.
18. Hallux varus to any degree, or hallux valgus >20 degrees.

(DualCompression Hindfoot Nail subjects only):
19. Requiring only a tibiotalar or subtalar arthrodesis
20. Patient requires bulk allograft or metal spacer implant to fill large bony defect and aid in limb salvage

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

All Products listed in Descriptions

  • ProStop
  • BioCompression Screw
  • TRIM-IT Drill Pin/TRIM-IT Spin Pin
  • Headless Compression Screw/Compression FT Screw
  • DynaNite Nitinol Staple
  • BioComposite SutureTak Anchor
  • Beveled Headed FT Screw
  • KreuLock Screws
  • ArthroFLEX dermal allograft
  • DualCompression Hindfoot Nail

Interventions

Products listed in Group/Cohort Description

Depending on approved indication per product

Primary outcome measure

  • To assess change in Visual Analogue Scale (VAS) survey [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]
  • To assess changes in Veterans RAND Health (VR-12) survey [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]
  • To assess changes in Foot and Ankle Ability Measures (FAAM) survey [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]
  • To assess change in Single Assessment Numeric Evaluation (SANE) survey [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]

Central Contacts and Locations

Central contacts

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Christopher Kreulen, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Muhammad Mutawakkil, MD

Atlantic Orthopaedic Specialists

Recruiting

Virginia Beach, Virginia, United States, 23462

Contacts

Ashley Suttmiller Coordinator

757-321-3360suttmillera@atlanticortho.com

Principal Investigator:

Blake Moore, MD

More Information

Sponsor

Arthrex, Inc.

Last update posted

Feb 11, 2026

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2026-02-11.