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Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)

Sponsor
Treace Medical Concepts, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05082012
Collaborator
(none)
200
Enrollment
8
Locations
27.4
Anticipated Duration (Months)
25
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.

Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Condition or Disease Intervention/Treatment Phase
  • Device: Treatment of Hallux Valgus
 N/A

Detailed Description

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery:

  1. To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure.

  2. To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes.

  3. To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction.

  4. To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis With Early Weight-Bearing After Lapiplasty® ProceDure Through a Mini-Incision™ Approach (Mini3D)
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Sep 17, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Radiographic Recurrence [24 months]

    To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure

Secondary Outcome Measures

  1. Radiographic Angular/Positional Alignment [pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure]

    Change in radiographic angular/positional alignment before/after the Lapiplasty® Procedure

  2. Radiographic Healing [12 months post Lapiplasty® Procedure]

    Union vs non-union -- Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint

  3. Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data [24 months post Lapiplasty® Procedure]

    Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data

  4. Time to start of weight-bearing in a boot [0-3 weeks, post Lapiplasty® Procedure]

    Time to start of weight-bearing in a boot

  5. Time to start of weight-bearing in a shoe [6 weeks, post Lapiplasty® Procedure]

    Time to start of weight-bearing in a shoe

  6. Time to return to full unrestricted activity [6 weeks - 12 months, post Lapiplasty® Procedure]

    Time to return to full unrestricted activity

  7. Change in Pain [0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure]

    Change in pain assess via Visual Analog Scale (VAS)

  8. Change in Quality of Life [6 months, 12 months, 24 months post Lapiplasty® Procedure]

    Change in quality of life via PROMIS-29, PROMIS-25, MOxFQ

  9. Change in Range of Motion [12 months, 24 months post Lapiplasty® Procedure]

    1st MTP dorsiflexion and plantarflexion

  10. Change in Radiographic Foot Length [12 months post Lapiplasty® Procedure]

    Change in radiographic foot length compared to baseline visit

  11. Change in Radiographic Foot Width [12 months post Lapiplasty® Procedure]

    Change in radiographic foot width compared to baseline visit

  12. Change in Swelling at Foot, Ankle & Mid-Calf (Circumference) [6 weeks and 4 months post Lapiplasty® Procedure]

    Change in swelling as compared to 0-2 week visit

  13. Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS) [4 months, 6 months, and 12 months post Lapiplasty® Procedure]

    Change in scar quality in comparison to baseline visit

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 58 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:

  1. Male and females between the ages 14 and 58 years at the time of consent;

  2. Closed physeal plates at the time of consent;

  3. Intermetatarsal angle is between 10.0˚ - 22.0˚;

  4. Hallux valgus angle is between 16.0˚ - 40.0˚;

  5. Willing and able to adhere to early weight-bearing instructions post-operatively;

  6. Capable of completing self-administered questionnaires;

  7. Acceptable surgical candidate, including use of general anesthesia;

  8. Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure;

  9. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits;

  10. Willing and able to provide written informed consent.

Exclusion Criteria:
Patients satisfying the following criteria will not be eligible for participation:

  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. Additional concomitant procedures outside of the 1st ray;

  4. Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test;

  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, including current use of nicotine patch;

  8. Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or HbA1c ≥7.0;

  9. Current clinical diagnosis of peripheral neuropathy or by assessment on 4-point monofilament test;

  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. Previously sensitized to titanium;

  14. Currently taking oral steroids or rheumatoid biologics;

  15. Currently taking immunosuppressant drugs;

  16. Insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease;

  17. Active, suspected or latent infection in the affected area;

  18. Use of synthetic or allogenic bone graft substitutes;

  19. Current diagnosis of metatarsus adductus (defined as MAA ≥ 23˚);

  20. Known keloid and hypertrophic scar forming;

  21. Scheduled to undergo a same-day bilateral procedure. Patient agrees to refrain from the Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for minimum of 6 months post index procedure;

  22. Patient has previously been enrolled into this study for a contralateral procedure;

  23. Scheduled for any concomitant procedure that would alter patient's ability to early weight-bear post-procedure;

  24. Patient requires an incision >4.0 cm to complete the procedure (determined pre-operatively or intra-operatively);

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

  26. Patient is currently 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 the Treace ALIGN3D™ study without ongoing protocol defined AE; these are not exclusionary;

  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

Locations

Site City State Country Postal Code
1 DOC - Decatur Orthopaedic Clinic Decatur Alabama United States 35601
2 DOC - Decatur Orthopaedic Clinic Hartselle Alabama United States 35640
3 Phoenix Foot and Ankle Institute Scottsdale Arizona United States 85251
4 Orlando Foot and Ankle Clinic - Waterford Lakes Office Orlando Florida United States 32825
5 JCMG - Podiatry Jefferson City Missouri United States 65109
6 Stonebriar Foot and Ankle Frisco Texas United States 75034
7 Foot & Ankle Associates of North Texas - Keller Keller Texas United States 76248
8 Sports Medicine Associates of San Antonio San Antonio Texas United States 78240

Sponsors and Collaborators

  • Treace Medical Concepts, Inc.

Investigators

  • Principal Investigator: Jody McAleer, DPM, FACFAS, JCMG - Podiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Treace Medical Concepts, Inc.
ClinicalTrials.gov Identifier:
NCT05082012
Other Study ID Numbers:
  • CP2021-1
First Posted:
Oct 18, 2021
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Hallux Valgus

Study Results

No Results Posted as of Aug 15, 2022