Evaluation of the Titan 3-D™ Wedge System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-15

Study Completion Date

2022-09-01

Brief Summary

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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 who receive one or more TITAN 3-D™ Wedges will obtain satisfactory levels of clinical healing and radiographic maintenance of correction at 6 months.

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Detailed Description

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Conditions

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Flat Foot Lateral Column Lengthening Medial Cuneiform Osteotomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Titan 3-D Wedge System

Subjects who receive one or more Titan 3D wedge(s).

Titan 3D Wedge System

Intervention Type DEVICE

Each subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure.

Interventions

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Titan 3D Wedge System

Each subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject has foot pain/discomfort on the foot in question.
2. The subject has activity limitations due to the foot in question.
3. The subject agrees to comply with the requirements of the study and complete the study measures.
4. The subject (or representative of the subject in the case of a minor) is willing and able to provide written informed consent.
5. The subject plans on undergoing an LCL procedure and/or medial cuneiform osteotomy with a TITAN 3-D™ Wedge.

Exclusion Criteria

1. The subject is pregnant.
2. The subject had been previously sensitized to titanium.
3. The subject is scheduled for a same day bilateral LCL procedure or medial cuneiform osteotomy procedure.
4. The subject is not expected to complete the study according to the investigation plan.
5. The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
6. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No