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

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

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

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus
• Intervention / Treatment: Device: HAVAI

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Billig, MBA; Phone Number: 02-6553333; Email: dbillig@bonfixmedical.com
• Study Contact Backup: Name: Ayelet Goldwasser, CTA; Phone Number: 052-5771144; Email: ayelet@duet-medical.com

Study Locations

• Israel
  • Haifa, Israel
    • Not yet recruiting
    • Rambam Hospital
    • Contact: Eyal Melamed, MD; Phone Number: 0502062277; Email: eyalfoot@gmail.com
    • Contact: Eyal Melamed, MD
  • Jerusalem, Israel, 91391
    • Recruiting
    • Bonfix Ltd
    • Contact: Daniel Billig, MBA; Phone Number: 02-6553333; Email: dbillig@bonfixmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXP; Implantation of a HAVAI device to correct HVA without osteotomy	Device: HAVAI; implantation of the HAVAI device to correct the IMA angle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Eyal Heller, MD, Rabin MC

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: 415-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No