Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Hallux Valgus Clinical Trial

— MTA3D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587569
• Other study ID #: CP2022-1
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Treace Medical Concepts, Inc.
• Contact: Cara Bethell
• Phone: (904) 373-5940
• Email: cbethell[@]treace.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 through 65 years with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and females between the ages 14 and 65 years at the time of consent

2. Closed physeal plates at the time of consent

3. Intermetatarsal angle is between 8.0° - 22.0°; OR True IMA of >10°, (IMA+MTA-15=True IMA)

4. Hallux valgus angle is between 12.0° - 50.0°

5. Metatarsus adductus angle based on Sgarlatos method >or=5° and <or=40°

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 or lesser toes/digits)

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. Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5°and talonavicular subluxation/uncovering >50%)

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus
• Metatarsus Adductus
• Metatarsus Varus

Intervention

Device:
• Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
Patients 14 years through 65 years with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated study duration will be 5 years post index procedure.

Locations

Country	Name	City	State
United States	Foot and Ankle Center of Iowa	Ankeny	Iowa
United States	Ohio Foot and Ankle Center	Canton	Ohio
United States	Foot and Ankle Center of the Rockies	Greeley	Colorado
United States	JCMG - Jefferson City Medical Group	Jefferson City	Missouri
United States	Foot and Ankle Associates of North Texas - Keller	Keller	Texas
United States	Ohio Foot and Ankle Center	Stow	Ohio
United States	Greater Pittsburgh Foot and Ankle Center	Wexford	Pennsylvania
United States	Coastal Maine Foot and Ankle	Yarmouth	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Treace Medical Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction	Successful correction is defined as two of the following three criteria: measured IMA <9.0°, HVA <15.0°, and TSP as =3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA >15.0°.	24 Months
Secondary	Radiographic Recurrence	Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA >20°.	24 Months
Secondary	Union vs non-Union	Evaluate clinical/radiographic healing (union vs non-union). Non-union is defined as pain and lucency at the 1st, 2nd, and/or 3rd TMT joint at 12 months post- Adductoplasty® Procedure and Lapiplasty® Procedure.	12 Months
Secondary	Clinical Complications	Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.	60 Months
Secondary	Weight-Bearing Recovery Time	Assessment of weight-bearing recovery time following the procedures. Weight-bearing will be measured in days and recorded based upon individual surgeon recovery protocol.	12 Months
Secondary	Time to Weight-Bear in Boot	Time to start of weight-bearing in boot, in days.	6 Weeks
Secondary	Time to Weight-Bear in Shoes	Time to start of weight-bearing in shoes, in days.	8 Weeks
Secondary	Time to Return to Unrestricted Activity	Time to return to full unrestricted activity, in days.	6 weeks - 6 months, post Lapiplasty® Procedure
Secondary	Change in Pain	Change in pain at the base of the big toe (bunion related), as well as the midfoot region for the operative foot only, assessed via the Visual Analog Scale (VAS) with 0-10 minimum and maximum values - with 0 being a better outcome and 10 being a worse outcome.	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.
Secondary	Change in Quality of Life	Change in Quality of Life, (PROMIS-29/PROMIS-25 and MOxFQ) defined as the total domain score measured.	6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Secondary	Change in Range of Motion	Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion	12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Secondary	Change in Osseous Foot Width	Change in osseous foot width - radiographically	12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit