Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
Recruiting
N/A
Interventional Study
Degenerative Instability
Spondylolisthesis
Post-discectomy Syndrome
Post-traumatic Instability
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 99 (estimated)
- Sponsor
- Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. · Industry
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About This Trial
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 objec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Each subject must meet all the following criteria to be enrolled in this study:
All subjects who had previously indicated for TLIF surgery can participate in this study, with the following evidence:
1. Has degenerative disease of the lumbosacral spine in one or two adjacent le…
Contacts