Clinical trial NCT03421665: Evaluation of the Titan 3-D™ Wedge System
Official title: A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Flat Foot
Lateral Column Lengthening
Medial Cuneiform Osteotomy
Keywords: titanium wedge
Evans
Cotton
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include males and females of all ages. Furthermore, it is likely that the majority of subjects enrolled in this study suffer from a flatfoot deformity; however, this study will not be restricted to only those diagnosed with flatfoot.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Healing
timeFrame: 6 Months
measure: Radiographic Maintenance of Correction
timeFrame: 6 Months
Secondary outcomes:
measure: Time to clinical/radiographic healing (union)
timeFrame: 24 Months
measure: Clinical complications
timeFrame: 24 Months
measure: Maintenance of implant position
timeFrame: 24 Months
measure: Maintenance of anatomical alignment
timeFrame: 24 Months
measure: Determine bone reaction, if any, to the device such as overgrowth or cystic lesions
timeFrame: 24 Months
measure: Determine rate of removal of the device and subsequent healing
timeFrame: 24 Months
measure: 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
timeFrame: 24 Months
measure: Change in VAS Pain Score across multiple time points
timeFrame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Change in AOFAS Ankle-Hindfoot and/or Midfoot Score across multiple time points
timeFrame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Change in PROMIS Pain Intensity Score across multiple time points
timeFrame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Change in PROMIS Mobility Score across multiple time points
timeFrame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Change in PROMIS Pain Interference Score across multiple time points
timeFrame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
measure: Compare the outcomes and complication rates of TITAN 3-D™ Wedges with previously published outcomes of historical controls, allograft bone and autograft bone
timeFrame: 24 Months
Other outcomes:
Locations:
Study officials:
References: