Clinical trial NCT03908203: Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
Official title: Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intervertebral Disc Degeneration
Spinal Fusion
Lead sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Sponsor class: OTHER_GOV
Collaborators: name: DePuy International
First posted: 2019-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Angle change at lumbar spine segment
timeFrame: At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)
Secondary outcomes:
measure: Improvement of Visual analog scale (VAS) back pain intensity
timeFrame: 3, 6, 12 months
measure: Improvement of Visual analog scale (VAS) leg pain intensity
timeFrame: 3, 6, 12 months
measure: Improvement of Oswestry Disability Index (ODI)
timeFrame: 3, 6, 12 months
measure: Fusion rate success
timeFrame: 12 months
measure: Range of Motion
timeFrame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
measure: Sagittal balance parameters
timeFrame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
measure: Disc height
timeFrame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
measure: Blood loss
timeFrame: Day of surgery
measure: Surgery duration
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study officials:
affiliation: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
name: Aleksandr V Krutko, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: