Degenerative Disc Disease
Conditions
Keywords
DDD, lumbar spine, fusion rate, degenerative disc disease
Brief summary
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.
Interventions
DEVICEROIA Interbody Cage with VerteBRIDGE plating
Sponsors
LDR Spine USA
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1 * Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s) * Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only * Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device * Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A® * Subject must be at least 21 years of age at the time of surgery * Subject must be willing to signed an informed consent document and return for a 12 month visit
Exclusion criteria
* Subject had more than Grade 1 spondylolisthesis at the operated level * Subject is a prisoner. * Subject was pregnant at the time of surgery. * Subject had an active infection or sepsis at the time of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fusion | 12 months after device implantation | Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Oswestry Disability Index | 12 months after device implantation | The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operated Subjects ROIA Interbody Cage with VerteBRIDGE plating | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Operated Subjects |
|---|---|
| Age, Continuous | 50.7 Years STANDARD_DEVIATION 11.9 |
| BMI (kg/mg^2) | 28.4 kg/mg^2 STANDARD_DEVIATION 4.6 |
| Current smoker | 9 Participants |
| Previous Lumbar Spine Surgery | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 51 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 5 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Number of Participants With Fusion
Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs
Time frame: 12 months after device implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Operated Subjects | Number of Participants With Fusion | 50 Participants |
Secondary
Mean Oswestry Disability Index
The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible
Time frame: 12 months after device implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Operated Subjects | Mean Oswestry Disability Index | 28.9 score on a scale | Standard Deviation 22.3 |