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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03748277
Other study ID # 15/11/18
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date February 15, 2020

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
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.


Recruitment information / eligibility

Status Terminated
Enrollment 132
Est. completion date February 15, 2020
Est. primary completion date February 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;

- intermittent claudication caused by stenosis of one lumbar spine segment;

- one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment

Exclusion Criteria:

- bilateral foraminal lumbar spine stenosis;

- lumbar spine stenosis more than one-level;

- spondylolisthesis II degree and more;

- sagittal imbalance;

- fusion the same lumbar spine segment after surgery previously;

- other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Decompression
Bilateral decompression
PLIF
Traditional open surgery
MIS TLIF
On the one side - Wiltse approach, on the other side - percutaneous
Screw Fixation
Transpedicular Screw Fixation

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry Disability Index (ODI) Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result).
Improvement of ODI post-operatively as compared to baseline
Day of hospital discharge (10-15 day after surgery)
Secondary Oswestry Disability Index (ODI) Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result).
Improvement of ODI as compared to baseline
3, 6 and 12 months
Secondary VAS (back, leg) Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).
Improvement of VAS back- and leg pain intensity as compared to baseline
Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months
Secondary Surgery duration Surgery duration, in minutes Day of surgery
Secondary Blood loss Blood loss, in milliliter Day of surgery
Secondary MRI capacity spine canal Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline Day of hospital discharge (10-15 day after surgery)
Secondary Bone fusion Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan) 12 months