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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Hallux Valgus

Treatments: Device: CyclaPlex Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02727595

HYMC-19-15

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

CyclaPlex Implant

Experimental group

Description:

Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.

Treatment:

Device: CyclaPlex Implant