Degenerative Disc Disease, Degenerative Scoliosis
Conditions
Brief summary
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
Detailed description
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
Interventions
DEVICETritanium Posterior Lumbar Cage
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
DEVICEAVS UniLIF PEEK Posterior Lumbar Cage
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
Sponsors
Stryker Spine
Riverside Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Study participants will not know which posterior lumbar cage they receive.
Intervention model description
Parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is skeletally mature * Subject has one or more of the following diagnoses: 1. Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to S1 a. DDD may include up to Grade 1 spondylolisthesis at the involved level(s) 2. Degenerative Scoliosis for which the interbody fusion device will be used as an adjunct to fusion * Subject has received 6 months of non-operative therapy * Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent * Subject agrees to comply with visit schedule and study assessments * Provision of signed and dated informed consent form * Subject stated willingness to comply with all study procedures and availability for the duration of the study * Subject is in good general health as evidenced by medical history
Exclusion criteria
* Subject is obese (BMI \> 40) * Subject is sensitive to titanium materials * Subject has an active infection at the operative site * Subject has marked local inflammation * Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis * Subject has any mental, trauma, or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care * Subject has any open wounds * Subject is pregnant or plans to become pregnant during the course of the study * Subject has inadequate tissue coverage over the operative site. * Subject has an neuromuscular deficit which places an unsafe load on the device during the healing period * Subject has any condition of senility, mental illness, or substance abuse * Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count. * Subject has prior fusion at the levels to be treated * Subject is incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fusion Success | 12 Months | CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation | Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain. |
| Change in Low Back Function | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation | Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled). |
| Change in Quality of Life: SF-36 PCS | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation. | Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function). |
| Number of Participants That Return to Work | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation | Subjects who were unable to work due to their back pain who return to work. |
| Ambulatory Status | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation | Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline. |
| Number of Participants With Serious Adverse Events | 6 weeks; 3 months; 6 months; and 12 months post operation | Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation |
| Change in Quality of Life: EQ-5d | Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation | Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AVS PEEK UniLIF Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
Study not completed due to COVID-19 | 2 |
| Tritanium Posterior Lumbar Cage Surgical placement of the Tritanium Posterior Lumbar Cage
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
Study not completed due to COVID-19. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | AVS PEEK UniLIF | Tritanium Posterior Lumbar Cage | Total |
|---|---|---|---|
| Age, Continuous | 64 years | 53.5 years | 58.75 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Number of Participants With Fusion Success
CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint
Time frame: 12 Months
Population: Four patients were initially enrolled; however, due to COVID-19, study enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No data to analyze.
Secondary
Ambulatory Status
Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze
Secondary
Change in Low Back Function
Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze
Secondary
Change in Quality of Life: EQ-5d
Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze
Secondary
Change in Quality of Life: SF-36 PCS
Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze
Secondary
Change in Visual Analogue Scale
Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze
Secondary
Number of Participants That Return to Work
Subjects who were unable to work due to their back pain who return to work.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze
Secondary
Number of Participants With Serious Adverse Events
Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation
Time frame: 6 weeks; 3 months; 6 months; and 12 months post operation
Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze