Trials / Completed
CompletedNCT03404232
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University Hospital, Aachen · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.
Detailed description
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO). Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dynesys DTO device (Zimmer Spine, Inc.) | All patients receive posterior hybrid instrumentation. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2016-12-31
- Completion
- 2017-12-31
- First posted
- 2018-01-19
- Last updated
- 2018-01-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03404232. Inclusion in this directory is not an endorsement.