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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02727595
Recruitment Status : Unknown
Verified March 2016 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Cycla Orthopedics Ltd.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Device: CyclaPlex Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. American Orthopedic Foot and Ankle Society (AOFAS) Score [ Time Frame: One year ]
    General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02727595

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Contact: Rafi Herzog, BSc

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Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Ori Hadash, MD   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Cycla Orthopedics Ltd.
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Principal Investigator: Ori Hadash, MD Hillel Yaffe Medical Center

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Responsible Party: Hillel Yaffe Medical Center Identifier: NCT02727595     History of Changes
Other Study ID Numbers: HYMC-19-15
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired