NCT02831868

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 4, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

July 11, 2016

Last Update Submit

August 30, 2018

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

EXP

EXPERIMENTAL

Implantation of a HAVAI device to correct HVA without osteotomy

Device: HAVAI

Interventions

HAVAIDEVICE

implantation of the HAVAI device to correct the IMA angle

EXP

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam Hospital

Haifa, Israel

NOT YET RECRUITING

Bonfix Ltd

Jerusalem, 91391, Israel

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Eyal Heller, MD

    Rabin MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Billig, MBA

CONTACT

02-6553333dbillig@bonfixmedical.com

Ayelet Goldwasser, CTA

CONTACT

052-5771144ayelet@duet-medical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 13, 2016

Study Start

March 1, 2018

Primary Completion

May 1, 2019

Study Completion

December 1, 2019

Last Updated

September 4, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)