A randomised blinded comparison of surgical intervention with the X STOPPK® interspinous process decompression versus surgical decompression for patients with intermittent neurogenic claudication caused by lumbar stenosis

A randomised blinded comparison of surgical intervention with the X STOPPK® interspinous process decompression versus surgical decompression for patients with intermittent neurogenic claudication caused by lumbar stenosis - Comparison of X STOPPK versus surgical decompression

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29809

Enrollment

386

Registered

2006-11-07

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Spinal stenosis & Pressure on the nerves causing leg pain

Interventions

Surgical intervention with the X STOPPK device.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - signed informed consent - is 18 - 80 years old at time of surgery - has intermittent neurogenic claudication - has received at least three months of conservative care therapy

Exclusion criteria

Exclusion criteria: - has cauda equina syndrome - has Paget's disease, severe osteoporosis or metastasis to the vertebrae - has had any surgery of the lumbar spine - has severe comorbid conditions - has any systemic disease that will interfere with the patient's welfare or outcome during the investigation

Design outcomes

Primary

Measure	Time frame
Symptoms and patient satisfaction will be measured with the Zurich Claudication Questionnaire.	—

Secondary

Measure	Time frame
The cost effectiveness as measured by the EuroQol questionnaire and costs obtained from the patient's diary.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)