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

Not Applicable

• Conditions: Hallux Valgus
• Interventions: Device: HAVAI

• Registration Number: NCT02831868
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-13
• Status Verified: 2018-03
• Study Start: 2018-03-01
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
2. Subject weighing <100 kg and body mass index (BMI) <32 kg/m2.
3. Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
4. Able and willing to comply with the requirements of the protocol.
5. Able to understand and sign written informed consent to participate in the study.

Exclusion Criteria

1. 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)

2. 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.

3. Aseptic necrosis or any deformity of MT2 head.

4. Aseptic necrosis of the MT1 head

5. Pregnant women or women with childbearing potential who are not obliged to take any contraception measures

6. 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)

7. ASA grade above 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXP	HAVAI	Implantation of a HAVAI device to correct HVA without osteotomy

Primary Outcome Measures

Name	Time	Method
A change in IMA angle	50 weeks	A change in IMA angle - compared to baseline using t test for repeated measures with 0.05 significance level.

Trial Locations

Locations (2)

Rambam Hospital; 🇮🇱 Haifa, Israel

Bonfix Ltd; 🇮🇱 Jerusalem, Israel