Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degeneration
- Sponsor
- Balgrist University Hospital
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- ODI (Oswestry Disability Index)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ODI (Oswestry Disability Index)
Time Frame: 2 years postoperative
To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery
Secondary Outcomes
- Revision surgery(2 years postoperative)
- Duration of surgery(Perioperative)
- Length of hospital stay(Perioperative)
- VAS (Visual Analogue Scale)(2 years postoperative)
- SSM satisfaction (Spinal Stenosis Measure)(2 years postoperative)
- EQ-5D (European Quality of Life Five Dimension)(2 years postoperative)
- Intraoperative blood loss(Perioperative)
- SSM symptoms/function (Spinal Stenosis Measure)(2 years postoperative)
- Complications(2 years postoperative)
- Use of analgesia(2 years postoperative)
- Use of physical therapy(2 years postoperative)