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

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03908203
• Other study ID #: NS02-02
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2020
• Source: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Spinal Fusion

Intervention

Procedure:
• Minimally 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.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan	DePuy International

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angle change at lumbar spine segment	Angle between endplates at the treated level of lumbar spine	At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)
Secondary	Improvement of Visual analog scale (VAS) back pain intensity	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).	3, 6, 12 months
Secondary	Improvement of Visual analog scale (VAS) leg pain intensity	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).	3, 6, 12 months
Secondary	Improvement of Oswestry Disability Index (ODI)	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).	3, 6, 12 months
Secondary	Fusion rate success	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.	12 months
Secondary	Range of Motion	To observe the disc mobility at the treated level	At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Secondary	Sagittal balance parameters	To observe sagittal balance as compared to baseline	At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Secondary	Disc height	To observe disc height at the treated level as compared to baseline	At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Secondary	Blood loss	Blood loss	Day of surgery
Secondary	Surgery duration	Surgery duration	Day of surgery