Trials / Completed
CompletedNCT04594980
Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis
An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | lumbar fusion | Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique. |
Timeline
- Start date
- 2022-01-20
- Primary completion
- 2024-02-27
- Completion
- 2026-03-01
- First posted
- 2020-10-20
- Last updated
- 2026-03-03
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT04594980. Inclusion in this directory is not an endorsement.