Clinical trial NCT04254250: Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
Official title: Observational Cohort Study Of The Efficacy Of Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intervertebral Disc Herniation
Lead sponsor: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with radicular leg pain with or without back pain secondary to single level disc herniation with neural compression confirmed on MRI and symptoms persisting for at least four weeks prior to surgery

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 observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .

It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.


Eligibility criteria: Inclusion Criteria:

- Age 18 to 60 years;

Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;

1. Radicular leg pain with or without back pain;
2. Symptoms persisting for at least four weeks prior to surgery;
3. Given written Informed Consent;
4. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
5. Visual Analogue Scale score at least 40/100 at baseline.

Exclusion Criteria:

1. More than one symptomatic level requiring multilevel surgical decompression
2. Stenosis any etiology at the same level;
3. Spondylolisthesis any etiology at the same level;
4. Prior lumbar spinal surgery at any level;
5. 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
6. Concurrent participation in another clinical study that may confound study results.

Primary outcomes:
measure: Reherniation rate
timeFrame: at 3 years follow-up term postoperatively
Secondary outcomes:
measure: Improvement of Oswestry Disability Index (ODI)
timeFrame: 6, 12, 18, 24, 30, 36 months follow up
measure: Improvement of Visual analog scale (VAS) leg pain intensity
timeFrame: 6, 12, 18, 24, 30, 36 months follow up
measure: Change from baseline in EQ-5D (EuroQl - 5 dimensional)
timeFrame: 6, 12, 18, 24, 30, 36 months follow up
measure: HTI Item (from SF-36)
timeFrame: 6, 12, 18, 24, 30, 36 months follow up
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Priorov National Medical Research Center of Traumatology and Orthopedics
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study officials:
References: