Clinical Trial: Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title:
Brief Summary: The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.
Detailed Summary:
Sponsor: Hillel Yaffe Medical Center
Current Primary Outcome: IMA Reduction [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: American Orthopedic Foot and Ankle Society (AOFAS) Score [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Hillel Yaffe Medical Center
Dates:
Date Received: March 30, 2016
Date Started: April 2016
Date Completion: September 2017
Last Updated: March 30, 2016
Last Verified: March 2016