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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02727595

Enrollment

Registered

2016-04-04

Start date

2016-04-30

Completion date

2017-09-30

Last updated

2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

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.

Interventions

DEVICECyclaPlex Implant

Button and suture type implant that will be implanted between the first and second metatarsal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Israel

Contacts

Primary ContactRafi Herzog, BSc

rherzog@netvision.net.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026