Evaluation of the Titan 3-D™ Wedge System

Withdrawn

• Conditions: Medial Cuneiform Osteotomy; Flat Foot; Lateral Column Lengthening
• Interventions: Device: Titan 3D Wedge System

• Registration Number: NCT03421665
• Lead Sponsor: Paragon 28

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-05
• Study Start: 2018-06-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Titan 3-D Wedge System	Titan 3D Wedge System	Subjects who receive one or more Titan 3D wedge(s).

Primary Outcome Measures

Name	Time	Method
Clinical Healing	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	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 Outcome Measures

Name	Time	Method
Maintenance of implant position	24 Months
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	Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility Score, Item Bank v2.0.; Raw Score Range: 15 (high level of difficulty) to 120 (no difficulty)
Clinical complications	24 Months	Complications due to the procedure
Time to clinical/radiographic healing (union)	24 Months	Evaluate time to clinical/radiographic healing (union vs. non-union) after a Titan 3D wedge procedure
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	American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot clinical score.; Pain: 0-40 points Function: 0-50 points Alignment: 0-10 points Total Score (sum): 0-100 points (higher score indicates better outcomes); American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot clinical score. Pain: 0-40 points Function: 0-45 points Alignment: 0-15 points Total Score (sum): 0-100 points (higher score indicates better outcomes)
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	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score, Item Bank v1.0, SF 3a.; Raw Score Range: 3 (no pain) to 15 (very severe pain)
Change in VAS Pain Score across multiple time points	Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months	Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.
Change in PROMIS Pain Interference Score across multiple time points	Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score, Item Bank v1.0, SF 6a.; Raw Score Range: 6 (no interference) to 30 (high level of interference)