Trials / Completed
CompletedNCT04208048
FLXfitTM 15 TLIF Interbody Fusion Device
Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 31 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- —
Summary
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.
Detailed description
The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FLXfit 15TM device | In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed. |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2022-03-01
- Completion
- 2022-08-22
- First posted
- 2019-12-23
- Last updated
- 2023-03-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04208048. Inclusion in this directory is not an endorsement.