Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle
NCT ID: NCT02831868
Last Updated: 2018-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-03-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EXP
Implantation of a HAVAI device to correct HVA without osteotomy
HAVAI
implantation of the HAVAI device to correct the IMA angle
Interventions
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HAVAI
implantation of the HAVAI device to correct the IMA angle
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Eyal Heller, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin MC
Locations
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Rambam Hospital
Haifa, , Israel
Bonfix Ltd
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Eyal Melamed, MD
Role: backup
Other Identifiers
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415-16
Identifier Type: -
Identifier Source: org_study_id
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