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

Hallux Valgus Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02727595
• Other study ID #: HYMC-19-15
• Status: Not yet recruiting
• Phase: N/A
• First received: March 30, 2016
• Last updated: March 30, 2016
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Hillel Yaffe Medical Center
• Contact: Rafi Herzog, BSc
• Email: rherzog[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Device:
• CyclaPlex Implant
Button and suture type implant that will be implanted between the first and second metatarsal

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center	Cycla Orthopedics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year	No
Secondary	American Orthopedic Foot and Ankle Society (AOFAS) Score	General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score	One year	No