Evaluation of the Titan 3-D™ Wedge System

Paragon 28

Status: Withdrawn

Conditions: Medial Cuneiform Osteotomy; Lateral Column Lengthening; Flat Foot

Treatments: Device: Titan 3D Wedge System

Study type: Observational

Funder types: Industry

Identifiers

NCT03421665

P03-SP-0001

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Titan 3-D Wedge System

Description:

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

Treatment:

Device: Titan 3D Wedge System