Trials / Withdrawn
WithdrawnNCT03421665
Evaluation of the Titan 3-D™ Wedge System
A Multicenter, Prospective, Post-Market Clinical Follow-Up Evaluation of the Titan 3-D™ Wedge System
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Paragon 28 · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-06-15
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
- First posted
- 2018-02-05
- Last updated
- 2018-10-15
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03421665. Inclusion in this directory is not an endorsement.