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Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art. The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives: * To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain. * To evaluate if implantation causes significant increase quality of life of the patients. * To evaluate if using the device can be considered as safe overall.
Details
| Lead sponsor | Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 99 |
| Start date | Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Oct 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Degenerative Instability
- Spondylolisthesis
- Post-discectomy Syndrome
- Post-traumatic Instability
Interventions
- ReSpace TiCell Cage
Countries
Hungary