RECRUITING

Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

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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

Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction. Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Official Title

Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)

Quick Facts

Study Start:2022-09-28

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05587569

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:14 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and females ≥14 years old at the time of consent 2. Closed physeal plates at the time of consent 3. Intermetatarsal angle is ≥8.0˚; OR True IMA of \>10°, (IMA+MTA-15=True IMA) 4. Hallux valgus angle is ≥12.0˚ 5. Metatarsus adductus angle based on Sgarlatos method ≥15° 6. Willing and able to adhere to post-op care instructions 7. Capable of completing self-administered questionnaires 8. Acceptable surgical candidate, including use of general anesthesia 9. Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure 10. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits 11. Willing and able to provide written informed consent 12. Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure	1. Previous surgery for hallux valgus on operative side 2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening) 3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints 4. Moderate-severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints 5. Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction 6. BMI \>40 kg/m² 7. Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch 8. Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes 9. Current clinical diagnosis of peripheral neuropathy 10. Current clinical diagnosis of fibromyalgia 11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD) 12. Current uncontrolled hypothyroidism 13. Current clinical diagnosis of chronic dependent edema 14. Previously sensitized to titanium 15. Currently taking oral steroids or rheumatoid biologics 16. Currently taking immunosuppressant drugs 17. Insufficient quantity or quality of bone to permit stabilization, conditions that inhibit healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease 18. Active, suspected, or latent infection in the affected area 19. Use of synthetic or allogenic bone graft substitutes 20. Use of non-Treace products for Index Procedure 21. Additional bone procedure needed during the index procedure to complete correction (additional metatarsal or tarsal bone osteotomy or fusion, first MTP fusion, calcaneal osteotomy, traditional medial eminence resection); 22. Scheduled to undergo a same-day bilateral procedure 23. Patient has previously been enrolled into this study for a contralateral procedure 24. Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure 25. Patient is actively involved with a workman's compensation case or is currently involved in litigation 26. Patient is currently in, or has participated in, a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE 27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up

Inclusion Criteria

Exclusion Criteria

1. Male and females ≥14 years old at the time of consent
2. Closed physeal plates at the time of consent
3. Intermetatarsal angle is ≥8.0˚; OR True IMA of \>10°, (IMA+MTA-15=True IMA)
4. Hallux valgus angle is ≥12.0˚
5. Metatarsus adductus angle based on Sgarlatos method ≥15°
6. Willing and able to adhere to post-op care instructions
7. Capable of completing self-administered questionnaires
8. Acceptable surgical candidate, including use of general anesthesia
9. Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure
10. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits
11. Willing and able to provide written informed consent
12. Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure

1. Previous surgery for hallux valgus on operative side
2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
4. Moderate-severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
5. Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction
6. BMI \>40 kg/m²
7. Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
8. Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
9. Current clinical diagnosis of peripheral neuropathy
10. Current clinical diagnosis of fibromyalgia
11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
12. Current uncontrolled hypothyroidism
13. Current clinical diagnosis of chronic dependent edema
14. Previously sensitized to titanium
15. Currently taking oral steroids or rheumatoid biologics
16. Currently taking immunosuppressant drugs
17. Insufficient quantity or quality of bone to permit stabilization, conditions that inhibit healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease
18. Active, suspected, or latent infection in the affected area
19. Use of synthetic or allogenic bone graft substitutes
20. Use of non-Treace products for Index Procedure
21. Additional bone procedure needed during the index procedure to complete correction (additional metatarsal or tarsal bone osteotomy or fusion, first MTP fusion, calcaneal osteotomy, traditional medial eminence resection);
22. Scheduled to undergo a same-day bilateral procedure
23. Patient has previously been enrolled into this study for a contralateral procedure
24. Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure
25. Patient is actively involved with a workman's compensation case or is currently involved in litigation
26. Patient is currently in, or has participated in, a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE
27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up

Contacts and Locations

Study Contact

Cara Bethell

CONTACT

(904) 373-5940

cbethell@treace.net

Shana Zink

CONTACT

(513) 265-0621

szink@treace.net

Principal Investigator

Paul Dayton, DPM

PRINCIPAL_INVESTIGATOR

Foot and Ankle Center of Iowa

Mark Easley, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Foot and Ankle Center of the Rockies

Greeley, Colorado, 80634

United States

Foot and Ankle Center of Iowa

Ankeny, Iowa, 50023

United States

Coastal Maine Foot and Ankle

Yarmouth, Maine, 04096

United States

JCMG - Jefferson City Medical Group

Jefferson City, Missouri, 65019

United States

Duke Orthopaedics Arringdon

Morrisville, North Carolina, 27560

United States

Ohio Foot and Ankle Center

Canton, Ohio, 44708

United States

Ohio Foot and Ankle Center

Stow, Ohio, 44224

United States

Greater Pittsburgh Foot and Ankle Center

Wexford, Pennsylvania, 15090

United States

Foot and Ankle Associates of North Texas - Keller

Keller, Texas, 76248

United States

Collaborators and Investigators

Sponsor: Treace Medical Concepts, Inc.

Paul Dayton, DPM, PRINCIPAL_INVESTIGATOR, Foot and Ankle Center of Iowa
Mark Easley, MD, PRINCIPAL_INVESTIGATOR, Duke University

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 Date2022-09-28

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2022-09-28

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

Metatarsus Adductus
Hallux Valgus
MTA3D

Additional Relevant MeSH Terms

Metatarsus Adductus
Hallux Valgus