Degenerative Disc Disease
Conditions
Keywords
arthroplasty, lumbar, disc
Brief summary
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
Detailed description
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF. This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.
Interventions
DEVICECHARITE
Lumbar Total Disc Replacement
Sponsors
DePuy Spine
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study, * Still have the original implant they received in their index surgery.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success | 5 Years | ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints | 5 Years | Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency |
Countries
United States
Outcome results
None listed