A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Paragon 28
- Primary Endpoint
- Clinical Healing
Study Overview
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 who receive one or more TITAN 3-D™ Wedges will obtain satisfactory levels of clinical healing and radiographic maintenance of correction at 6 months.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Clinical Healing
Time Frame: 6 Months
Evaluate clinical healing following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Clinical healing is defined as lack of pain over the osteotomy site.
Radiographic Maintenance of Correction
Time Frame: 6 Months
Evaluate 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. Radiographic maintenance of correction is defined as the absence of a clinically relevant change in radiographic measures across post-operative time points.
Secondary Outcomes
- Determine rate of removal of the device and subsequent healing(24 Months)
- Change in anatomical and radiographic angular/positional alignment before and after an LCL procedure and/or medial cuneiform osteotomy using a TITAN 3-D™ Wedge(24 Months)
- Change in PROMIS Mobility Score across multiple time points(Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Clinical complications(24 Months)
- Time to clinical/radiographic healing (union)(24 Months)
- Maintenance of implant position(24 Months)
- Maintenance of anatomical alignment(24 Months)
- Change in AOFAS Ankle-Hindfoot and/or Midfoot Score across multiple time points(Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Compare the outcomes and complication rates of TITAN 3-D™ Wedges with previously published outcomes of historical controls, allograft bone and autograft bone(24 Months)
- Determine bone reaction, if any, to the device such as overgrowth or cystic lesions(24 Months)
- Change in PROMIS Pain Intensity Score across multiple time points(Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Change in VAS Pain Score across multiple time points(Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Change in PROMIS Pain Interference Score across multiple time points(Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)