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
About this trial
This is an interventional treatment trial for Hallux Valgus
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
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
NCT ID
NCT02727595
First Posted
March 30, 2016
Last Updated
March 30, 2016
Sponsor
Hillel Yaffe Medical Center
Collaborators
Cycla Orthopedics Ltd.
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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