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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: American Orthopedic Foot and Ankle Society (AOFAS) Score [ Time Frame: One year ]

General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score


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