Lapiplasty: 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.
Study 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.
Eligibility
Sex
ALL
Min age
14 Years
Max age
58 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
* Active, suspected or latent infection in the affected area
* Use of synthetic or allogenic bone graft substitutes
* Current diagnosis of metatarsus adductus (defined as MAA ≥ 23 ̊)
* Scheduled to undergo a same - 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
* Patient has previously been enrolled into this study for a contralateral procedure
* Scheduled for any concomitant procedure that would alter patient's ability to early weight-bear post-procedure
* Patient is actively involved with a workman's compensation case or is currently involved in litigation
* Patient is currently or has participated in a clinical study in the last 30 days prior to signing
* 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 outcome measure(s)
Radiographic recurrence of hallux valgus — 24 Months Defined as IMA ≥ 12, HVA ≥ 20 and TSP as ≥ 4 at 24 Months post Lapiplasty Procedure
Trial sites (7)
Facility
City
Region
Status
Foot & Ankle Center of Northern Colorado
Greeley
Colorado
Foot & Ankle Center of Iowa
Ankeny
Iowa
Jefferson City Medical Group, P.C.
Jefferson City
Missouri
Desert Orthopaedic Center
Las Vegas
Nevada
University of Pennsylvania/Penn Medicine
Philadelphia
Pennsylvania
UT Southwestern
Dallas
Texas
Stonebriar Foot & Ankle
Frisco
Texas
More Treace Medical Concepts, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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