Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction

Not Applicable

Withdrawn

• Conditions: Spinal Fusion; Intervertebral Disc Degeneration
• Interventions: Procedure: Minimally invasive one-level lumbar deformity correction

• Registration Number: NCT03908203
• Lead Sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-06
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11
• Study Start: 2020-10-01
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Minimally invasive one-level lumbar deformity correction	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
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
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

Trial Locations

Locations (1)

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan; 🇷🇺 Novosibirsk, Russian Federation