Degenerative Disc Disease
Conditions
Brief summary
The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.
Interventions
PROCEDURElumbar spinal arthroplasty + Maverick™
All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
Sponsors
Medtronic Spinal and Biologics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Degenerative Disc Disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies * Foraminal stenosis due to loss of disc height * Back pain and/or leg pain.
Exclusion criteria
* Spondylolisthesis at the affected or adjacent level * Posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy * Obesity * Osteoporosis * Metallic allergy to cobalt-chromium-molybdenum alloys * Psychosis * Infection * Spinal canal stenosis * Overlying thoracolumbar kyphosis * Systemic infection or infection at the site of surgery * Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated * Diseases of bone metabolism * Pregnancy * Signs of local inflammation * Fever or Leukocytosis * Grossly distorted anatomy caused by congenital abnormalities * Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count (this also includes: spinal active oncology pathology; not healed fracture at treated or adjacent level) * Any case where the implants or components selected would be too large or too small to achieve a successful result * Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance * Any patient unwilling to follow postoperative instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) | 6 months | The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS) | 6 months | Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced. 0 = no pain, 10 = worst possible pain |
Countries
Canada, France, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumbar Spinal Arthroplasty + Maverick™ Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc. | 134 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12 Months Follow up | Lost to Follow-up | 9 |
| 6 Months Follow up | Lost to Follow-up | 11 |
| 6 Months Follow up | Missed visit | 8 |
| Discharge | Death | 1 |
| Discharge | Missed visit | 1 |
| Enrolled | Patient not implanted | 4 |
| Enrolled | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lumbar Spinal Arthroplasty + Maverick™ |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 9 |
| Region of Enrollment Canada | 5 participants |
| Region of Enrollment France | 79 participants |
| Region of Enrollment Germany | 50 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 134 |
| serious Total, serious adverse events | 57 / 134 |
Outcome results
Primary
Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.
Time frame: 6 months
Population: Reduction of disability was calculated for patients having available data at both baseline and 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lumbar Spinal Arthroplasty + Maverick™ | Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) | -25.4 units on a scale |
p-value: <0.0001t-test, 2 sided
Secondary
Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)
Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced. 0 = no pain, 10 = worst possible pain
Time frame: 6 months
Population: Reduction of disability was calculated for patients having available data at both baseline and 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lumbar Spinal Arthroplasty + Maverick™ | Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS) | -4.0 units on a scale |
p-value: <0.0001t-test, 2 sided