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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831868
• Other study ID #: 415-16
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Rabin Medical Center
• Contact: Daniel Billig, MBA
• Phone: 02-6553333
• Email: dbillig[@]bonfixmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Device:
• HAVAI
implantation of the HAVAI device to correct the IMA angle

Locations

Country	Name	City	State
Israel	Rambam Hospital	Haifa
Israel	Bonfix Ltd	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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