Trials / Unknown
UnknownNCT02831868
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Rabin Medical Center · Academic / Other
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HAVAI | implantation of the HAVAI device to correct the IMA angle |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2019-05-01
- Completion
- 2019-12-01
- First posted
- 2016-07-13
- Last updated
- 2018-09-04
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02831868. Inclusion in this directory is not an endorsement.