Degenerative Disc Disease
Conditions
Keywords
DDD, degenerative disc disease, cervical spine, fusion rate
Brief summary
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.
Interventions
DEVICEROIC 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
* Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1. * The subject can have the ROI-C device at only one level. * Autograft must have been used with the ROI-C device. * Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery. * Subject must be at least 21 years of age at the time of surgery
Exclusion criteria
* No BMP was used in the interbody cage * Subject was a prisoner at the time of surgery * 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 |
|---|---|---|
| Percentage of Participants With Fusion | 12 months or more after device implantation; mean follow up 20.7 months | Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | 12 months (Last available visit) post surgery | NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operated Subjects With ROI-C Device Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Operated Subjects With ROI-C Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| Age, Continuous | 51.9 Years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 42 / 110 |
| serious Total, serious adverse events | 2 / 110 |
Outcome results
Primary
Percentage of Participants With Fusion
Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.
Time frame: 12 months or more after device implantation; mean follow up 20.7 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Operated Subjects With ROI-C Device | Percentage of Participants With Fusion | 99.1 Percentage of Participants |
Secondary
Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain
NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain.
Time frame: 12 months (Last available visit) post surgery
Population: Operated Subjects
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Operated Subjects With ROI-C Device | Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | NDI | 19.0 Units on a Scale |
| Operated Subjects With ROI-C Device | Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | VAS Neck | 26.5 Units on a Scale |
| Operated Subjects With ROI-C Device | Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | VAS Left Arm | 15.3 Units on a Scale |
| Operated Subjects With ROI-C Device | Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | VAS Right Arm | 12.5 Units on a Scale |