Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity

Not Applicable

• Conditions: Hallux Valgus
• Interventions: Device: CyclaPlex Implant

• Registration Number: NCT02727595
• Lead Sponsor: Hillel Yaffe Medical Center

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 Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-03-30
• Study Start: 2016-04
• Study First Posted: 2016-04-04
• Last Update Posted: 2016-04-04
• Primary Completion: 2017-08
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Weight less than 100 kilos
• IMA greater than 12 degrees
• IMA less than 7 degrees

Exclusion Criteria

• Diabetics
• Known osteoporosis
• Known allergy or hypersensitivity to metals
• Gout or any systemic inflammatory arthropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyclaPlex Implant	CyclaPlex Implant	Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.

Primary Outcome Measures

Name	Time	Method
IMA Reduction	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.

Secondary Outcome Measures

Name	Time	Method
American Orthopedic Foot and Ankle Society (AOFAS) Score	One year	General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel