Degenerative Disc Disease
Conditions
Keywords
fusion, lateral interbody fusion system, lumbar spine, degenerative disc disease
Brief summary
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.
Interventions
DEVICEAvenue® L Interbody Fusion System (LDR Spine)
PEEK, intervertebral cage for interbody fusion of the lumbar spine
Sponsors
LDR Spine USA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage) * Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery * Subject should have had a minimum of 6 months of non-operative treatment prior to surgery * The placement of the Avenue L device must be a primary surgery * Subject must be willing to sign the consent form and be able to return for all follow up visits.
Exclusion criteria
* Subject must not have had prior surgery at the operative level(s) * Subject is known to have substance or alcohol addictions * Subject has lateral curvature of the spine (scoliosis, all types) * Subject is a prisoner * Subject is pregnant * Subject has an active infection or sepsis at the time of surgery * Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Rate | 12 months after device implantation | Number of participants with fused disc space as measured radiographically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Oswestry Disability Index (ODI) | preop, 3 mo, 6 mo, 12 mo post op | The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
| Visual Analog Scale (VAS) of Back Pain | preop, 3 mo, 6 mo, 12 mo | The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either no pain or worst imaginable pain. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operated Subjects Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1
Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Termination by Sponsor | 2 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Operated Subjects |
|---|---|
| Age, Continuous | 54.5 Years |
| BMI (kg/m^2) | 31.5 kg/m^2 |
| Previous Lumbar Surgery | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 12 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
| Surgical Level L2-L3 | 3 Participants |
| Surgical Level L2-L4 | 1 Participants |
| Surgical Level L3-L4 | 3 Participants |
| Surgical Level L4-L5 | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Fusion Rate
Number of participants with fused disc space as measured radiographically
Time frame: 12 months after device implantation
Population: Poor enrollment led to early termination and low number of participants available for analysis. Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months. Only 3 of 6 participants reaching 12 month follow up had radiographs available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Operated Subjects | Fusion Rate | 3 Participants |
Secondary
Mean Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: preop, 3 mo, 6 mo, 12 mo post op
Population: Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Operated Subjects | Mean Oswestry Disability Index (ODI) | Preop | 53 score on a scale |
| Operated Subjects | Mean Oswestry Disability Index (ODI) | 3 months | 46 score on a scale |
| Operated Subjects | Mean Oswestry Disability Index (ODI) | 6 months | 45 score on a scale |
| Operated Subjects | Mean Oswestry Disability Index (ODI) | 12 months | 37 score on a scale |
Secondary
Visual Analog Scale (VAS) of Back Pain
The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either no pain or worst imaginable pain. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100.
Time frame: preop, 3 mo, 6 mo, 12 mo
Population: Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Operated Subjects | Visual Analog Scale (VAS) of Back Pain | Preop | 77 units on a scale |
| Operated Subjects | Visual Analog Scale (VAS) of Back Pain | 3 months | 42 units on a scale |
| Operated Subjects | Visual Analog Scale (VAS) of Back Pain | 6 months | 29 units on a scale |
| Operated Subjects | Visual Analog Scale (VAS) of Back Pain | 12 months | 23 units on a scale |