Intervertebral Disc Degeneration, Spinal Fusion
Conditions
Brief summary
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia. The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine. It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.
Interventions
PROCEDUREMinimally invasive one-level lumbar deformity correction
The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion.
Sponsors
DePuy International
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Given written Informed Consent; * Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1; * Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain; * Symptoms persisting for at least three months prior to surgery; * Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Exclusion criteria
* Lumbar deformation of non-degenerative etiology; * Spondylolisthesis grade II or higher (25% slip or greater) of any etiology; * Patient that has already undergone a lumbar fusion surgery; * Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study * Concurrent participation in another clinical study that may confound study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angle change at lumbar spine segment | At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first) | Angle between endplates at the treated level of lumbar spine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Visual analog scale (VAS) leg pain intensity | 3, 6, 12 months | To observe the improvement of VAS leg pain as compared to baseline through follow-up terms. Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). |
| Improvement of Oswestry Disability Index (ODI) | 3, 6, 12 months | To observe the improvement of ODI as compared to baseline through follow-up terms Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 % (the best result, the patient has no limitations in physical activity). Maximum - 100% (the worst result, patient is not physically active at all). |
| Fusion rate success | 12 months | To observe the Fusion rate (I, II, III or IV grade according to Tan). Grade I - complete fusion; Grade II - partial fusion; Grade III - unipolar pseudarthrosis; Grade IV - bipolar pseudarthrosis. |
| Range of Motion | At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months | To observe the disc mobility at the treated level |
| Improvement of Visual analog scale (VAS) back pain intensity | 3, 6, 12 months | To observe the improvement of VAS back pain as compared to baseline through follow-up terms. Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). |
| Disc height | At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months | To observe disc height at the treated level as compared to baseline |
| Blood loss | Day of surgery | Blood loss |
| Surgery duration | Day of surgery | Surgery duration |
| Sagittal balance parameters | At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months | To observe sagittal balance as compared to baseline |
Countries
Russia
Outcome results
None listed