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NCT Number: NCT02006901

Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

Introduction: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. Many spine surgeons today perform microdecompression for central lumbar spinal stenosis.

Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery (NORspine).

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Key information

Conditions

Spinal Stenosis Bone Diseases Central Nervous System Diseases Musculoskeletal Diseases Nervous System Diseases Spinal Cord Compression Spinal Cord Diseases Spinal Cord Injuries Spinal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St.Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of central lumbar spinal stenosis
  • Operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in the time period between October 2006 and December 2011
  • Included in the NORspine registry

Exclusion criteria

  • History of lumbar fusion
  • Previous surgery in the lumbar spine
  • Discectomy as part of the decompression
  • Associated pathological entities such as disc herniation, spondylolisthesis or scoliosis.

Treatment and study plan

Microdecompression

Procedure

a minimal invasive surgical technique

laminectomy

Procedure

The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets

Primary outcomes

  1. change in Oswestry Disability Index

    Time frame: between baseline and 12-months follow-up

    collected through the Norwegian Registry for Spine Surgery (NORspine)

Secondary outcomes

  1. changes in health-related quality of life

    Time frame: between baseline and 12-months follow-up

    measured by Euro-Qol-5D, collected through the Norwegian Registry for Spine Surgery (NORspine)

  2. patient reported post-operative complications

    Time frame: 3 months

    wound infection, urinary tract infection, pneumonia, pulmonary embolism, and deep venous thrombosis

  3. surgeon reported complication

    Time frame: reported at discharge (expected average hospital stay of 3 days)

    intraoperative hemorrhage requiring blood replacement, unintentional durotomy, cardiovascular complications, respiratory complications, anaphylactic reactions, and wrong level surgery

  4. Length of hospital stay

    Time frame: reported at discharge (expected average hospital stay of 3 days)

    Length of hospital stay before discharge

  5. Length of surgery

    Time frame: reported at discharge (expected average hospital stay of 3 days)

    Length of surgery

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis - An Observational Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2013
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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