Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
NCT ID: NCT02727595
Last Updated: 2016-04-04
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
5 participants
INTERVENTIONAL
2016-04-30
2017-09-30
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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CyclaPlex Implant
Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.
CyclaPlex Implant
Button and suture type implant that will be implanted between the first and second metatarsal
Interventions
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CyclaPlex Implant
Button and suture type implant that will be implanted between the first and second metatarsal
Eligibility Criteria
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Inclusion Criteria
* IMA greater than 12 degrees
* IMA less than 7 degrees
Exclusion Criteria
* Known osteoporosis
* Known allergy or hypersensitivity to metals
* Gout or any systemic inflammatory arthropathy
20 Years
75 Years
ALL
No
Sponsors
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Cycla Orthopedics Ltd.
INDUSTRY
Hillel Yaffe Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Ori Hadash, MD
Role: PRINCIPAL_INVESTIGATOR
Hillel Yaffe Medical Center
Locations
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Hillel Yaffe Medical Center
Hadera, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYMC-19-15
Identifier Type: -
Identifier Source: org_study_id
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