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

NCT ID: NCT02727595

Last Updated: 2016-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CyclaPlex Implant

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

Group Type EXPERIMENTAL

CyclaPlex Implant

Intervention Type DEVICE

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

Interventions

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CyclaPlex Implant

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cycla Orthopedics Ltd.

INDUSTRY

Sponsor Role collaborator

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ori Hadash, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Rafi Herzog, BSc

Role: CONTACT

Facility Contacts

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Ori Hadash, MD

Role: primary

Other Identifiers

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HYMC-19-15

Identifier Type: -

Identifier Source: org_study_id

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