Chronic Low Back Pain, Degenerative Disc Disease, Facet Joint Disease, Pseudo Arthrosis Post Anterior Instrumentation
Conditions
Brief summary
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments. The primary objective of this study is to determine the rate of re-operations at the index level(s). The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.
Interventions
DEVICEFacet Wedge spinal system
Sponsors
Synthes GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects diagnosed with at least one of the following: * Degenerative Disc Disease (DDD); * Degenerative facet joint disease (isolated facet based symptomatic back pain); * Pseudoarthrosis post anterior instrumentation; 2. Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1; 3. Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Exclusion criteria
Preoperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reoperation rate at the index level(s) | at two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the radiographic range of motion (ROM) at the index levels | Pre-treatment, 6 months, 12 months, 24 months | — |
| patient (back and leg) pain reported on a Numeric Rating Scale (NRS) | pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months. | — |
| functional success based on results from the Oswestry Disability Index (ODI) | Pre-treatment, 6 weeks, 6 months, 12 months, 24 months | — |
| Adverse events | Throughout the study | The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety. |
Countries
Germany, Slovakia
Outcome results
None listed