Status:
WITHDRAWN
Evaluation of the Titan 3-D™ Wedge System
Lead Sponsor:
Paragon 28
Conditions:
Flat Foot
Lateral Column Lengthening
Eligibility:
All Genders
Brief Summary
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Subjects w...
Eligibility Criteria
Inclusion
- The subject has foot pain/discomfort on the foot in question.
- The subject has activity limitations due to the foot in question.
- The subject agrees to comply with the requirements of the study and complete the study measures.
- The subject (or representative of the subject in the case of a minor) is willing and able to provide written informed consent.
- The subject plans on undergoing an LCL procedure and/or medial cuneiform osteotomy with a TITAN 3-D™ Wedge.
Exclusion
- The subject is pregnant.
- The subject had been previously sensitized to titanium.
- The subject is scheduled for a same day bilateral LCL procedure or medial cuneiform osteotomy procedure.
- The subject is not expected to complete the study according to the investigation plan.
- The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
- The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated to be non-compliant.
Key Trial Info
Start Date :
June 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03421665
Start Date
June 15 2018
End Date
September 1 2022
Last Update
October 15 2018
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