Trials / Withdrawn
WithdrawnNCT03162666
Patient Outcomes Using an Expandable Spacer
Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Globus Medical Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
Detailed description
The evaluation is based on the following elements. 1. Safety as measured by the rate of serious operative and post-operative complications. 2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline. 3. Global and segmental lumbar lordosis (LL) Patients will be followed upto 24 months post-operative
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ALTERA | degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis |
Timeline
- Start date
- 2017-02-28
- Primary completion
- 2020-11-06
- Completion
- 2020-11-06
- First posted
- 2017-05-22
- Last updated
- 2021-08-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03162666. Inclusion in this directory is not an endorsement.