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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23242

Enrollment

340

Registered

2014-07-21

Start date

2014-06-10

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Included are patients with neurogenic claudication or radicular leg pain due to spinal stenosis which do not respond to conservative therapy for at least 6 months.

Interventions

Intervention: The intervention arm will be minimal invasive surgery with decompression through a small incision and a computer assisted fusion with an interbody fusion device and posterior instrument

Eligibility

Inclusion criteria

Inclusion criteria: A subject must meet all of the following 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, at one or two levels. - Spine is expected to destabilize after simple lumbar decompressive surgery. - 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: A potential subject who meets any of the following criteria will be excluded: - 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

Primary

Measure	Time frame
The primary outcome parameter is speed of recovery on Oswestry Disability Index (ODI).	—

Secondary

Measure	Time frame
Secondary outcome parameters are ODI, cost (Cost intervention, postoperative health care use, and loss of productivity), VAS leg pain, VAS back pain, transformed Quality of Life VAS, Quality-Adjusted-Life Years (QALY) based on measured EuroQol (EQ-5D), ZCQ, Likert perceived recovery patient, Likert perceived recovery care provider, SF36, complications, operative morbidity (scar length, muscle damage assessed with CRP values), and fusion.	—

Measure

Time frame

Secondary outcome parameters are ODI, cost (Cost intervention, postoperative health care use, and loss of productivity), VAS leg pain, VAS back pain, transformed Quality of Life VAS, Quality-Adjusted-Life Years (QALY) based on measured EuroQol (EQ-5D), ZCQ, Likert perceived recovery patient, Likert perceived recovery care provider, SF36, complications, operative morbidity (scar length, muscle damage assessed with CRP values), and fusion.

—

Contacts

Public ContactW.C.H. Jacobs

w.c.h.jacobs@lumc.nl071-5261490

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)