Clinical trial NCT05587569: Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Official title: Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metatarsus Adductus
Hallux Valgus
Keywords: Metatarsus Adductus
Hallux Valgus
MTA3D
Lead sponsor: Treace Medical Concepts, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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:

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. 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 \[first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion (other than Weil osteotomies)\];
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

Primary outcomes:
measure: Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
timeFrame: 24 Months
Secondary outcomes:
measure: Radiographic Recurrence
timeFrame: 24 Months
measure: Union vs non-Union
timeFrame: 12 Months
measure: Clinical Complications
timeFrame: 60 Months
measure: Weight-Bearing Recovery Time
timeFrame: 12 Months
measure: Time to Weight-Bear in Boot
timeFrame: 6 Weeks
measure: Time to Weight-Bear in Shoes
timeFrame: 8 Weeks
measure: Time to Return to Unrestricted Activity
timeFrame: 6 weeks - 6 months, post Lapiplasty® Procedure
measure: Change in Pain
timeFrame: 0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.
measure: Change in Quality of Life
timeFrame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
measure: Change in Range of Motion
timeFrame: 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
measure: Change in Osseous Foot Width
timeFrame: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Other outcomes:
Locations:
city: Greeley
country: United States
facility: Foot and Ankle Center of the Rockies
state: Colorado
city: Ankeny
country: United States
facility: Foot and Ankle Center of Iowa
state: Iowa
city: Yarmouth
country: United States
facility: Coastal Maine Foot and Ankle
state: Maine
city: Jefferson City
country: United States
facility: JCMG - Jefferson City Medical Group
state: Missouri
city: Morrisville
country: United States
facility: Duke Orthopaedics Arringdon
state: North Carolina
city: Canton
country: United States
facility: Ohio Foot and Ankle Center
state: Ohio
city: Stow
country: United States
facility: Ohio Foot and Ankle Center
state: Ohio
city: Wexford
country: United States
facility: Greater Pittsburgh Foot and Ankle Center
state: Pennsylvania
city: Keller
country: United States
facility: Foot and Ankle Associates of North Texas - Keller
state: Texas
Study officials:
affiliation: Foot and Ankle Center of Iowa
name: Paul Dayton, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Mark Easley, MD
role: PRINCIPAL_INVESTIGATOR
References: