RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04715139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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. 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	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. 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. 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. 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

Inclusion Criteria

Exclusion 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.
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.
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

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.
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.
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.
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

Contacts and Locations

Study Contact

Justin Moss, DHSc

CONTACT

770 584 4972

justin.moss@arthrex.com

Study Locations (Sites)

UC Davis Medical Center

Sacramento, California, 95817

United States

TOA Research Foundation

Nashville, Tennessee, 37209

United States

Barrett Podiatry

San Antonio, Texas, 78258

United States

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, 23462

United States

Collaborators and Investigators

Sponsor: Arthrex, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2020-12-01

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

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