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NCT03748277
Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
NA trial testing Decompression in Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis) in 132 participants. Terminated before completion.
15 February 2019
Quick facts
| Lead sponsor | Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 132 |
| Start date | 15 November 2018 |
| Primary completion | 15 February 2019 |
| Estimated completion | 15 February 2020 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Decompression
- PLIF
- MIS TLIF
- Screw Fixation
Conditions studied
- Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis) — all drugs for Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis) →
Sponsor
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Who can join
Adults 18 to 70, any sex, with Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03748277
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Decompression
Trials testing the same drug.
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- NCT03495661 — Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis · NA · completed
- NCT03115983 — LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis · NA · active not recruiting
- NCT02902250 — The Comparative Study About the Effect of Vertebral Body Decompression Procedure · NA · completed
Other Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan trials
Trials by the same sponsor.
- NCT04408846 — Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis · NA · withdrawn
- NCT03908203 — Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction · NA · withdrawn
- NCT04254250 — Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03748277 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Last refreshed: 14 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03748277.
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