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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Button and suture type implant that will be implanted between the first and second metatarsal
Hillel Yaffe Medical Center
Hadera, Israel
IMA Reduction
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.
Time frame: One year
American Orthopedic Foot and Ankle Society (AOFAS) Score
General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score
Time frame: One year
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