Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
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|ClinicalTrials.gov Identifier: NCT02727595|
Recruitment Status : Unknown
Verified March 2016 by Hillel Yaffe Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 4, 2016
Last Update Posted : April 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus||Device: CyclaPlex Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: CyclaPlex Implant
Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.
Device: CyclaPlex Implant
Button and suture type implant that will be implanted between the first and second metatarsal
- IMA Reduction [ Time Frame: One year ]The IMA angle is measured pre-op and post-op on x-ray images using internal software. The IMA at end of study should be less than 10 degrees or a reduction of more than 5 degrees.
- American Orthopedic Foot and Ankle Society (AOFAS) Score [ Time Frame: One year ]General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727595
|Contact: Rafi Herzog, BScemail@example.com|
|Hillel Yaffe Medical Center||Not yet recruiting|
|Hadera, Israel, 38100|
|Contact: Ori Hadash, MD firstname.lastname@example.org|
|Principal Investigator:||Ori Hadash, MD||Hillel Yaffe Medical Center|