Trials / Unknown
UnknownNCT01601301
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Ellipse Technologies, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
Detailed description
Subject data will be reviewed at the following visits: * Preoperative * Operative * Every 7 to 14 days through Distraction Phase * Every 4 to 6 weeks through Consolidation Phase * 6-Month Post-Consolidation * 12-Month Post-Consolidation * 18-Month Post-Consolidation * 24-Month Post-Consolidation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PRECICE System | Lenthening of either the tibia or femur with the PRECICE System. |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2012-05-18
- Last updated
- 2018-02-05
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01601301. Inclusion in this directory is not an endorsement.