Evaluation of the Titan 3-D™ Wedge System

October 10, 2018 updated by: Paragon 28

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to clinical/radiographic healing (union)
Time Frame: 24 Months
Evaluate time to clinical/radiographic healing (union vs. non-union) after a Titan 3D wedge procedure
24 Months
Clinical complications
Time Frame: 24 Months
Complications due to the procedure
24 Months
Maintenance of implant position
Time Frame: 24 Months
24 Months
Maintenance of anatomical alignment
Time Frame: 24 Months
24 Months
Determine bone reaction, if any, to the device such as overgrowth or cystic lesions
Time Frame: 24 Months
24 Months
Determine rate of removal of the device and subsequent healing
Time Frame: 24 Months
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
Time Frame: 24 Months
24 Months
Change in VAS Pain Score across multiple time points
Time Frame: 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.
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
Time Frame: 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)
Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Intensity Score across multiple time points
Time Frame: 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)
Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Mobility Score across multiple time points
Time Frame: 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)
Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Interference Score across multiple time points
Time Frame: 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)
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
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paragon 28

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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