Cost-effectiveness of minimal invasive spinal fusion compared to open fusion for patients with spinal stenosis with neurogenic claudication or radicular leg pain.

Cost-effectiveness of minimal invasive spinal fusion compared to open fusion for patients with spinal stenosis with neurogenic claudication or radicular leg pain. - Cost-effectiveness of Minimal Invasive fusion (DOMINO)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41403

Enrollment

340

Registered

2014-06-02

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low back pain Neurogenic claudication radicular leg pain

Interventions

Intervention: One level, minimal invasive surgery for decompression and interbody fusion. Minimal invasive access for decompression is accomplished by a muscle splitting approach using tubular retra

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Neurogenic claudication or radicular leg pain. - Complaints are due to MRI confirmed existence of lytic or degenerative spondylolisthesis of maximal 50% or Meyerding Grade II, or spinal stenosis accompanied by severe facet degeneration (grade 2 or 3 according to Weishaupt (Skeletal Radiol 1999; 28 (4):215-9), at one or two levels - Single or double level fusion indicated. - Insufficient response to conservative therapy (physical therapy, analgesic medications, or trans-foraminal corticosteroid injections) for at least 6 months. - Age is between and including 18-70 years. - Be able to understand the Dutch language and comprehend the questionnaires and patient information. - Patients signed informed consent.

Exclusion criteria

Exclusion criteria: - Iatrogenic Spondylolisthesis or more than 50% or more than Meyerding Grade II. - Inflammatory arthritis, Osteoporosis or other metabolic bone disease to a degree that it would influence fusion. - Contraindication for surgery.

Design outcomes

Secondary

Measure	Time frame
Secondary outcome parameters are Quality of life (EuroQoL, transformed QoL VAS, SF36), cost, VAS leg and VAS back pain, ZCQ, Likert perceived recovery, Likert satisfaction, complications, perioperative morbidity, fusion.	—

Primary

Measure	Time frame
Primary outcome parameter is the time spent in recovered state during the first year on the Oswestry Disability Index (ODI).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)