NCT02727595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

March 30, 2016

Last Update Submit

March 30, 2016

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (1)

  • American Orthopedic Foot and Ankle Society (AOFAS) Score

    One year

Study Arms (1)

CyclaPlex Implant

EXPERIMENTAL

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

Device: CyclaPlex Implant

Interventions

CyclaPlex ImplantDEVICE

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

CyclaPlex Implant

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weight less than 100 kilos
  • IMA greater than 12 degrees
  • IMA less than 7 degrees

You may not qualify if:

  • Diabetics
  • Known osteoporosis
  • Known allergy or hypersensitivity to metals
  • Gout or any systemic inflammatory arthropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Ori Hadash, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafi Herzog, BSc

CONTACT

rherzog@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 4, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

April 4, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)