Clinical trial NCT06024785: Vertebropexy - Randomized-controlled Trial
Official title: Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degeneration
Spinal Stenosis
Fusion of Spine
Keywords: degenerative lumbar spinal disease
decompression
fusion
vertebropexy
ligamentous fixation
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Stratification: Indication for decompression (study arm 1) or fusion (study arm 2)
* Randomization within study arm 1 and study arm 2 between study intervention and control intervention
Primary purpose: TREATMENT

Brief summary: To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)

Detailed description: The global share of people over the age of 65 years has been consistently on the rise over the past few decades, and is still projected to increase. The increasing life expectancy, overall advances in medical care and therefore, the higher average age of people seeking surgical treatment lead to increasing numbers of spine surgeries: Spinal fusion is one of the most frequently used surgical treatment modalities for spinal disorders with 7.6 million per year worldwide (EU: 700,000, USA: 450,000, CH: 9000) and provides stability by internal rigid fixation of the spine with screws, rods and bony fusion. Although producing reliable short-term results with rapid pain relief and positive effects on patient outcome, implant-related complications, painful pseudarthrosis (non-union of bone), screw loosening, and adjacent segment disease lead to one-third of patients requiring reoperation within 15 years. These complications might be evoked by altered biomechanics with redistribution of loads and subsequently increased stress at the bone-implant interface as well as long fusions leading to relevant, irreversible loss of motion. Therefore, a new treatment modality which reinforces bony spinal segments with ligaments, the so called "vertebropexy", was recently developed by Farshad et al. The goal is to achieve targeted stabilization of the spine by inserting ligamentous allografts to counteract instability, without immobilizing the segment. Furthermore, it might provide additional stabilization after decompression surgery and therefore reduce revision surgery rates due to instability in clinically relevant directions as flexion-extension or anterior shear stress. However, to become a broadly accepted surgical alternative to existing surgical techniques for degenerative lumbar spinal disease like dorsal fusion and spinal decompression surgery, the new technique must provide convincing long-term results superior to those of these established procedures which is the primary objective of this randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Single-level or two-level lumbar surgery needed
* Indication for decompression surgery in patients with spinal canal stenosis and additional stable degenerative listhesis (without facet joint effusion ≥ 2mm)
* Indication for fusion surgery in patients with spinal canal stenosis and additional unstable degenerative listhesis (facet joint effusion ≥ 2mm), in patients with foraminal stenosis and additional degenerative listhesis, and in patients with segment degeneration of the disc
* Understanding in German language

Exclusion criteria:

* Indication for decompression and/or fusion surgery in patients with solely disc herniation, fractures, lytic listhesis, tumor
* Patients undergoing revision surgery for infection
* Patients undergoing revision surgery on the same level if bony structures have been removed (e.g. prior laminectomy or midline decompression)
* Patients undergoing revision surgery in case of prior fusion surgery
* Inability to understand the study for linguistic or cognitive reasons
* Anticipated clinical follow-up of less than 6 weeks after inclusion
* Participation in other clinical trials

Primary outcomes:
measure: ODI (Oswestry Disability Index)
timeFrame: 2 years postoperative
Secondary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: 2 years postoperative
measure: SSM symptoms/function (Spinal Stenosis Measure)
timeFrame: 2 years postoperative
measure: SSM satisfaction (Spinal Stenosis Measure)
timeFrame: 2 years postoperative
measure: EQ-5D (European Quality of Life Five Dimension)
timeFrame: 2 years postoperative
measure: Revision surgery
timeFrame: 2 years postoperative
measure: Complications
timeFrame: 2 years postoperative
measure: Duration of surgery
timeFrame: Perioperative
measure: Length of hospital stay
timeFrame: Perioperative
measure: Intraoperative blood loss
timeFrame: Perioperative
measure: Use of analgesia
timeFrame: 2 years postoperative
measure: Use of physical therapy
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References:
citation: Widmer J, Cornaz F, Scheibler G, Spirig JM, Snedeker JG, Farshad M. Biomechanical contribution of spinal structures to stability of the lumbar spine-novel biomechanical insights. Spine J. 2020 Oct;20(10):1705-1716. doi: 10.1016/j.spinee.2020.05.541. Epub 2020 May 28.
citation: Farshad M, Tsagkaris C, Widmer J, Fasser MR, Cornaz F, Calek AK. Vertebropexy as a semi-rigid ligamentous alternative to lumbar spinal fusion. Eur Spine J. 2023 May;32(5):1695-1703. doi: 10.1007/s00586-023-07647-y. Epub 2023 Mar 17.
citation: Calek AK, Widmer J, Fasser MR, Farshad M. Lumbar vertebropexy after unilateral total facetectomy. Spine J. 2023 Nov;23(11):1730-1737. doi: 10.1016/j.spinee.2023.07.005. Epub 2023 Jul 13.
citation: Calek AK, Altorfer F, Fasser MR, Widmer J, Farshad M. Interspinous and spinolaminar synthetic vertebropexy of the lumbar spine. Eur Spine J. 2023 Sep;32(9):3183-3191. doi: 10.1007/s00586-023-07798-y. Epub 2023 Jun 7.