Trials / Unknown
UnknownNCT05610397
Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 Levels
Multicenter, Retrospective, Observational Clinical Study to Evaluate Clinical Outcome Measures and Safety Profiles for Patients With SDDD Treated With STALIF® C, or M, Ti or FLX Implants for 1 and 2 Levels.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Centinel Spine · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Retrospective, Observational Multi-Center study, utilizing patients diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with STALIF® C, or M, Ti and/or FLX implants at one or two levels.
Detailed description
The study is intended to codify the performance of the STALIF family of products. Its design is to provide retrospective data derived from the patient's medical and surgical chart and prospectively assess the treating surgeon and patient on their level of satisfaction post-operative up to present. All subjects who sign an informed consent will be included in the prospective data collection via chart review at the individual investigational sites. The prospective data will come from subjects who complete the designated patient assessments as well as the treating surgeon. The data collection period will include surgeries performed between 2014 to present. The analysis will support the safety profile of the product family and allow for comparison to the available literature as well as between device types (Ti versus FLX). Furthermore, data from this study will support post-market surveillance requirements for the STALIF family of products.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | STALIF® | STALIF® C, or M, Ti or FLX |
Timeline
- Start date
- 2023-04-24
- Primary completion
- 2024-04-30
- Completion
- 2024-09-01
- First posted
- 2022-11-09
- Last updated
- 2023-01-12
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05610397. Inclusion in this directory is not an endorsement.