Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05082012
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Treace Medical Concepts, Inc.

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
Hallux Valgus Bunion Device: Treatment of Hallux Valgus Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 17, 2021
Estimated Primary Completion Date : September 17, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion


Intervention Details:
  • Device: Treatment of Hallux Valgus
    Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.
    Other Name: Lapiplasty® Mini-Incision™ Procedure


Primary Outcome Measures :
  1. Radiographic Recurrence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 weeks, post Lapiplasty® Procedure ]
    Time to start of weight-bearing in a shoe

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

  7. Change in Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months, 24 months post Lapiplasty® Procedure ]
    1st MTP dorsiflexion and plantarflexion

  10. Change in Radiographic Foot Length [ Time Frame: 12 months post Lapiplasty® Procedure ]
    Change in radiographic foot length compared to baseline visit

  11. Change in Radiographic Foot Width [ Time Frame: 12 months post Lapiplasty® Procedure ]
    Change in radiographic foot width compared to baseline visit

  12. Change in Swelling at Foot, Ankle & Mid-Calf (Circumference) [ Time Frame: 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) [ Time Frame: 4 months, 6 months, and 12 months post Lapiplasty® Procedure ]
    Change in scar quality in comparison to baseline visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 58 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05082012


Contacts
Layout table for location contacts
Contact: Cara Bethell (904) 373-5940 ext 1317 cbethell@treace.net
Contact: Shana Zink (513) 265-0621 szink@treace.net

Locations
Layout table for location information
United States, Alabama
DOC - Decatur Orthopaedic Clinic Recruiting
Decatur, Alabama, United States, 35601
Contact: Rebecca McWhirter, CRNP    256-350-0362    rstephenson@docorthopaedic.com   
Principal Investigator: Justin Daigre, MD         
DOC - Decatur Orthopaedic Clinic Recruiting
Hartselle, Alabama, United States, 35640
Contact: Rebecca McWhirter    256-350-0362    rstephenson@docorthopaedic.com   
Principal Investigator: Justin Daigre, MD         
United States, Arizona
Phoenix Foot and Ankle Institute Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Jeffrey E McAlister, DPM    602-761-7819    jeff.mcalister@phoenixfai.com   
Principal Investigator: Jeffrey E McAlister, DPM         
United States, Missouri
JCMG - Podiatry Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Lauren Livesay, BHS, CCRP    573-556-7785    lauren.livesay@avacare.com   
Contact: Lisa Word, MSN, RN    (573) 556-7785    lisa.word@avacare.com   
Principal Investigator: Jody McAleer, DPM, FACFAS         
Sub-Investigator: William Duke, DPM         
United States, Texas
Stonebriar Foot and Ankle Recruiting
Frisco, Texas, United States, 75034
Contact: Robert Taylor, DPM    972-712-4161    bobbyerl@msn.com   
Contact: Angela Knowles, PMAC    (972) 712-4161    angela.knowles@sbcglobal.net   
Principal Investigator: Robert Taylor, DPM         
Foot & Ankle Associates of North Texas - Keller Recruiting
Keller, Texas, United States, 76248
Contact: Paul Steinke, DPM    817-416-6155    steinke@faant.com   
Principal Investigator: Paul Steinke, DPM         
Sports Medicine Associates of San Antonio Recruiting
San Antonio, Texas, United States, 78240
Contact: Marque Allen, DPM    210-699-8326    allenmarque@gmail.com   
Principal Investigator: Marque Allen, DPM         
Sponsors and Collaborators
Treace Medical Concepts, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jody McAleer, DPM, FACFAS JCMG - Podiatry
Layout table for additonal information
Responsible Party: Treace Medical Concepts, Inc.
ClinicalTrials.gov Identifier: NCT05082012    
Other Study ID Numbers: CP2021-1
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases