Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Last updated: February 11, 2025
Sponsor: Treace Medical Concepts, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bunion

Treatment

Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure

Clinical Study ID

NCT05587569
CP2022-1
  • Ages 14-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion 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 pregnancytest 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 toreturn 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 footfor minimum of 6 months post index procedure

Exclusion

Exclusion Criteria:

  1. Previous surgery for hallux valgus on operative side

  2. Previous surgeries on operative foot involving fusion of foot or ankle joints (otherthan hammertoe, lesser toes/digits, or posterior muscle lengthening)

  3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rdtarsometatarsal 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 conditionthat may affect the outcome of the tarsometatarsal realignment, or a condition thatrequires concomitant surgical correction

  6. BMI >40 kg/m²

  7. Current nicotine user in any form including vaping, smoking, oral ingestion or useof nicotine patch

  8. Current clinical diagnosis of diabetes or currently taking medication for treatmentof diabetes

  9. Current clinical diagnosis of peripheral neuropathy

  10. Current clinical diagnosis of fibromyalgia

  11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex SympatheticDystrophy (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 thatinhibit healing (not including pathological fractures) and conditions causing poorblood 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 toweight-bear post-procedure

  25. Patient is actively involved with a workman's compensation case or is currentlyinvolved in litigation

  26. Patient is currently in, or has participated in, a clinical study in the last 30days prior to signing informed consent or is considering participation in anotherresearch protocol during this study. Exceptions to this include survey clinicalstudies with no treatment or if subject is greater than 12 months post procedure ineither 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, mayjeopardize the patient's well-being, the soundness of this clinical study, or couldinterfere with provision of informed consent, completion of tests, therapy, orfollow-up

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
Phase:
Study Start date:
September 28, 2022
Estimated Completion Date:
December 31, 2029

Study Description

The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery:

  1. To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure.

  2. To determine whether the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, effectively corrects and maintains triplane anatomical alignment of the 1st, 2nd and 3rd metatarsals, the hallux position, the sesamoid position, and the foot width.

Connect with a study center

  • Foot and Ankle Center of the Rockies

    Greeley, Colorado 80634
    United States

    Active - Recruiting

  • Foot and Ankle Center of Iowa

    Ankeny, Iowa 50023
    United States

    Active - Recruiting

  • Coastal Maine Foot and Ankle

    Yarmouth, Maine 04096
    United States

    Active - Recruiting

  • JCMG - Jefferson City Medical Group

    Jefferson City, Missouri 65019
    United States

    Active - Recruiting

  • Duke Orthopaedics Arringdon

    Morrisville, North Carolina 27560
    United States

    Active - Recruiting

  • Ohio Foot and Ankle Center

    Canton, Ohio 44708
    United States

    Active - Recruiting

  • Ohio Foot and Ankle Center

    Stow, Ohio 44224
    United States

    Active - Recruiting

  • Greater Pittsburgh Foot and Ankle Center

    Wexford, Pennsylvania 15090
    United States

    Active - Recruiting

  • Foot and Ankle Associates of North Texas - Keller

    Keller, Texas 76248
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.