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

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HAVAI
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Hospital
  • Bonfix LtdRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EXP

Arm Description

Implantation of a HAVAI device to correct HVA without osteotomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 11, 2016
Last Updated
August 30, 2018
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02831868
Brief Title
Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXP
Arm Type
Experimental
Arm Description
Implantation of a HAVAI device to correct HVA without osteotomy
Intervention Type
Device
Intervention Name(s)
HAVAI
Intervention Description
implantation of the HAVAI device to correct the IMA angle
Primary Outcome Measure Information:
Title
A change in IMA angle
Description
A change in IMA angle - compared to baseline using t test for repeated measures with 0.05 significance level.
Time Frame
50 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Billig, MBA
Phone
02-6553333
Email
dbillig@bonfixmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayelet Goldwasser, CTA
Phone
052-5771144
Email
ayelet@duet-medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Heller, MD
Organizational Affiliation
Rabin MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eyal Melamed, MD
Phone
0502062277
Email
eyalfoot@gmail.com
First Name & Middle Initial & Last Name & Degree
Eyal Melamed, MD
Facility Name
Bonfix Ltd
City
Jerusalem
ZIP/Postal Code
91391
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Billig, MBA
Phone
02-6553333
Email
dbillig@bonfixmedical.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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