Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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 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

EXCLUSION CRITERIA

Exclusion Criteria:


  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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (904) 373-5940Email iconEmail Study Center

Study’s details


Contition
Metatarsus Adductus,Hallux Valgus
Age
14 - 65
Phase
NA
Participants needed
80
Est. Completion Date
Dec 31, 2029
Treatment type
INTERVENTIONAL

Sponsor
Treace Medical Concepts, Inc.
ClinicalTrials.gov identifier
NCT05587569
Study number
CP2022-1

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