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Evaluation of the Titan 3-D™ Wedge System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421665
Recruitment Status : Withdrawn (Sponsor decided to pursue an alternative study prior to subject enrollment.)
First Posted : February 5, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Paragon 28

Study Description
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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.

Condition or disease Intervention/treatment
Flat Foot Lateral Column Lengthening Medial Cuneiform Osteotomy Device: Titan 3D Wedge System

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System
Estimated Study Start Date : June 15, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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

  2. Clinical complications [ Time Frame: 24 Months ]
    Complications due to the procedure

  3. Maintenance of implant position [ Time Frame: 24 Months ]
  4. Maintenance of anatomical alignment [ Time Frame: 24 Months ]
  5. Determine bone reaction, if any, to the device such as overgrowth or cystic lesions [ Time Frame: 24 Months ]
  6. Determine rate of removal of the device and subsequent healing [ Time Frame: 24 Months ]
  7. 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 ]
  8. 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.

  9. 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)


  10. 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)


  11. 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)


  12. 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)


  13. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Paragon 28
ClinicalTrials.gov Identifier: NCT03421665    
Other Study ID Numbers: P03-SP-0001
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Paragon 28:
titanium wedge
Evans
Cotton
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
 Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities