(Cost) effectiveness of open Microdiscectomy vs. percutaneous transforaminal endoscopic discectomy (PTED) for patients with lumbosacral radicular syndrome due to a lumbar disc herniation

(Cost) effectiveness of open Microdiscectomy vs. percutaneous transforaminal endoscopic discectomy (PTED) for patients with lumbosacral radicular syndrome due to a lumbar disc herniation - PTED for LSRS (The PTED Trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55448

Enrollment

682

Registered

2015-06-09

Start date

2016-02-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

lumbar disc herniation

Interventions

Standard treatment (Open microdiscectomy) Open microdiscectomy is to be conducted as follows: General or spinal anesthesia is to be administered. Verification is to be performed using a C-arm and th

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • 18-70 years of age; • > 16 weeks of persistent radicular irritation without motor or sensory loss in the leg or > 6 weeks of radiating pain with- or without motor or sensory loss in the leg; • indication for an operation according to consensus; • MRI demonstrating lumbar disc herniation with nerve compression with or without concomitant spinal or lateral recess stenosis or sequestration; • sufficient knowledge of the Dutch language in order to complete forms and follow instructions independently.

Exclusion criteria

Exclusion criteria: • previous surgery on the same or adjacent disc level; • cauda equina syndrome (CES); • spondylytic or degenerative spondylolisthesis; • pregnancy; • severe comorbid medical or psychiatric disorder (ASA>2); • severe caudal or cranial sequestration; • moving abroad at short notice.

Design outcomes

Primary

Measure	Time frame
Primary outcome is: self-report leg pain (0-100 visual analogue scale (VAS)) which will be measured at various intervals throughout the year (the day following treatment, 2, 4, and 6 weeks, 3, 6, 9, 12, 24 and 60 months).	—

Secondary

Measure	Time frame
Secondary outcomes: back pain (0-100 VAS), and functional status (Oswestry Disability Index (ODI)), self-perceived recovery (single question measured on a 7-point Likert scale), quality of life (SF-36), patient satisfaction (single question), health valuations (EQ-5D), and complications, such as re-operative rate, or length of hospital stay. Patients will also receive a questionnaire at 24 months wherein the primary and secondary outcomes are measured with the exception of direct and indirect costs. These measures, however, do not play a role as primary endpoint.	—

Measure

Time frame

Secondary outcomes: back pain (0-100 VAS), and functional status (Oswestry Disability Index (ODI)), self-perceived recovery (single question measured on a 7-point Likert scale), quality of life (SF-36), patient satisfaction (single question), health valuations (EQ-5D), and complications, such as re-operative rate, or length of hospital stay. Patients will also receive a questionnaire at 24 months wherein the primary and secondary outcomes are measured with the exception of direct and indirect costs. These measures, however, do not play a role as primary endpoint.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)