WithdrawnNot Applicable

Evaluation of the Titan 3-D™ Wedge System

Stopped: Sponsor decided to pursue an alternative study prior to subject enrollment.

0Started 2018-06-15

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

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Clinical Healing

Timeframe: 6 Months

Radiographic Maintenance of Correction

Timeframe: 6 Months

Trial details

NCT IDNCT03421665

SponsorParagon 28

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-01

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