Clinical Research Directory

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