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

March 30, 2016 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CyclaPlex Implant
Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.
Device: CyclaPlex Implant
Button and suture type implant that will be implanted between the first and second metatarsal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IMA Reduction
Time Frame: 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.
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

Cycla Orthopedics Ltd.

Investigators

  • Principal Investigator: Ori Hadash, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-19-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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