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

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CyclaPlex Implant
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyclaPlex Implant

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

American Orthopedic Foot and Ankle Society (AOFAS) Score
General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score

Full Information

First Posted
March 30, 2016
Last Updated
March 30, 2016
Sponsor
Hillel Yaffe Medical Center
Collaborators
Cycla Orthopedics Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02727595
Brief Title
Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
Collaborators
Cycla Orthopedics Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CyclaPlex Implant
Arm Type
Experimental
Arm Description
Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.
Intervention Type
Device
Intervention Name(s)
CyclaPlex Implant
Intervention Description
Button and suture type implant that will be implanted between the first and second metatarsal
Primary Outcome Measure Information:
Title
IMA Reduction
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
American Orthopedic Foot and Ankle Society (AOFAS) Score
Description
General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafi Herzog, BSc
Email
rherzog@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ori Hadash, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ori Hadash, MD
Email
cafregel@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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