Early Weight-Bearing After the Lapiplasty Procedure

NCT03740282 | Active Not Recruiting FDA Device

• 1 other identifier: CP2018-1
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 7

Brief Summary

The objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery:

• The study will determine the radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure.
• The study will determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes.
• The study will assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction.
• The study will evaluate the quality of life and pain scores following the Lapiplasty® Procedure.

Conditions

Hallux Valgus; Bunion

Keywords

arthrodesis; bunion; early weight-bearing; lapidus; hallux valgus

Outcome Measures

Primary Outcomes (1)

• Radiographic recurrence of hallux valgus

  Defined as IMA ≥ 12, HVA ≥ 20 and TSP as ≥ 4 at 24 Months post Lapiplasty Procedure

  24 Months

Secondary Outcomes (11)

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

  Pre-operatively, 6 Weeks, 4 Months, 6 Months, 12 Months, 24 Months, 36 Month, 48 Months, 60 Months

• Clinical/radiographic healing

  12 Months

• Clinical complications

  24 Months

• Time to start of weight-bearing in boot

  0-3 Weeks

• Time to start of weight-bearing in shoes

  0-12 Weeks

Study Arms (1)

Lapiplasty

EXPERIMENTAL

All study participants receiving Lapiplasty procedure

Device: Lapiplasty

Interventions

Lapiplasty DEVICE

Patients 14 years through 58 years with symptomatic hallux valgus who are treated with the Lapiplasty System will begin weight-bearing by 3 weeks and follow a defined post-operative protocol.

Lapiplasty

Eligibility Criteria

• Age: 14 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and females between the ages 14 and 58 years at the time of consent
• Closed physeal plates at the time of consent
• Intermetatarsal angle is between 10.0 ̊ - 22.0 ̊
• Hallux valgus angle is between 16.0 ̊ - 40.0 ̊
• Willing and able to adhere to early weight-bearing instructions post-operatively
• Capable of completing self - administered questionnaires
• Acceptable surgical candidate, including use of general anesthesia
• Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure
• Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits
• Willing and able to provide written informed consent

You may not qualify if:

• Previous surgery for hallux valgus on operative side
• Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits)
• Additional arthrodesis outside the first tarsometatarsal joint (other than: arthrodesis between the medial cuneiform and intermediate cuneiform and/or base of 2nd metatarsal; arthrodesis of hammertoe proximal interphalangeal joint or lesser toes/digits)
• Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test
• Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination \<5 ̊and talonavicular subluxation/uncovering \>50%)
• BMI \>40 kg/m²
• Current nicotine user, including current use of nicotine patch
• Current clinical diagnosis of diabetes with fasting plasma glucose \> 126 mg/dL and/or HbA 1c ≥7.0
• Current clinical diagnosis of peripheral neuropathy or by assessment on 4 - point monofilament test
• Current clinical diagnosis of fibromyalgia
• Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
• Current uncontrolled hypothyroidism
• Previously sensitized to titanium
• Currently taking oral steroids or rheumatoid biologics
• Currently taking immunosuppressant drugs

Sponsors & Collaborators

• Treace Medical Concepts, Inc.: lead

Study Sites (7)

Foot & Ankle Center of Northern Colorado

Greeley, Colorado, 80634, United States

Location

Foot & Ankle Center of Iowa

Ankeny, Iowa, 50023, United States

Location

Jefferson City Medical Group, P.C.

Jefferson City, Missouri, 65109, United States

Location

Desert Orthopaedic Center

Las Vegas, Nevada, 89121, United States

Location

University of Pennsylvania/Penn Medicine

Philadelphia, Pennsylvania, 19106, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Stonebriar Foot & Ankle

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion; Ankylosis

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Joint Diseases

Study Officials

• Dane Wukich, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 14, 2018
• Study Start: November 6, 2018
• Primary Completion: May 1, 2023
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)