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Evaluation of the Titan 3-D™ Wedge System

NCT03421665 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-10-15

No results posted yet for this study

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.

Conditions

  • Flat Foot
  • Lateral Column Lengthening
  • Medial Cuneiform Osteotomy

Interventions

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.

Sponsors & Collaborators

  • Paragon 28

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2022-09-01
Completion
2022-09-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421665 on ClinicalTrials.gov