Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle

Study Overview
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Brief Summary
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A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)

Official Title
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Multi Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of HAVAI, a Minimally Invasive Implant Composed of Spring, Double Anchor and Suture, Versus Standard of Care 1st Metatarsal Osteotomy, for Correction of Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity

Conditions
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Hallux Valgus

Intervention / Treatment
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* Device: HAVAI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit. Subject weighing <100 kg and body mass index (BMI) <32 kg/m2. Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°. Able and willing to comply with the requirements of the protocol. Able to understand and sign written informed consent to participate in the study. Exclusion Criteria: Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ) History of: a. Severe Diabetes mellitus (defined as existence of: i. More than 10 years duration ii. HbA1C 8.0 < iii. any known complications of diabetes (PVD, Nephropathy [CR>1.3], retinopathy, IHD)) b. Claudication, known peripheral vascular disease or no palpable pulses (DP or TP). c. Known rheumatoid or inflammatory disease. d. X-ray evidence of moderate osteoarthritis of MTPJ-1 or TMTJ-1. e. neurological conditions associated with spasticity or lower limb paralysis. f. Prior operation on MT1 or MT2. g. Fracture (past or present) of MT1 or MT2. Aseptic necrosis or any deformity of MT2 head. Aseptic necrosis of the MT1 head Pregnant women or women with childbearing potential who are not obliged to take any contraception measures Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) ASA grade above 2

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXP<br>Implantation of a HAVAI device to correct HVA without osteotomy | Device: HAVAI<br>* implantation of the HAVAI device to correct the IMA angle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in IMA angle | A change in IMA angle - compared to baseline using t test for repeated measures with 0.05 significance level. | 50 weeks |