Evaluation of the Titan 3-D™ Wedge System

A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System

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 Overview

• Status: Withdrawn
• Conditions: Flat Foot; Lateral Column Lengthening; Medial Cuneiform Osteotomy
• Intervention / Treatment: Device: Titan 3D Wedge System

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: Titan 3D Wedge System; Each subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Healing	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.	6 Months
Radiographic Maintenance of Correction	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.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical/radiographic healing (union)	Evaluate time to clinical/radiographic healing (union vs. non-union) after a Titan 3D wedge procedure	24 Months
Clinical complications	Complications due to the procedure	24 Months
Maintenance of implant position		24 Months
Maintenance of anatomical alignment		24 Months
Determine bone reaction, if any, to the device such as overgrowth or cystic lesions		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 VAS Pain Score across multiple time points	Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.	Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in AOFAS Ankle-Hindfoot and/or Midfoot Score across multiple time points	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)	Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Intensity Score across multiple time points	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)	Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Mobility Score across multiple time points	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)	Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Interference Score across multiple time points	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)	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

Collaborators and Investigators

• Sponsor: Paragon 28

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2018
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: titanium wedge; Evans; Cotton
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: P03-SP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No