UnknownNot Applicable

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

Israel30 participantsStarted 2018-03-01

Plain-language summary

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

Who can participate

Age range20 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✕. 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

What they're measuring

A change in IMA angle

Timeframe: 50 weeks

Trial details

NCT IDNCT02831868

SponsorRabin Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05

Contact for this trial

Daniel Billig, MBA

02-6553333 dbillig@bonfixmedical.com

View on ClinicalTrials.gov More Hallux Valgus trials