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NCT Number: NCT05140733

Outcomes of Patients With Foraminal Stenosis

The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. In this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.

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Key information

Conditions

Lumbar Foraminal Stenosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

About this study

Control: 1-2 levels fusion surgery Intervention: neural foraminotomy

Inclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain

Exclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis > 10cm)

Surgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.

Statistical analysis means: T-test

Who can participate

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

Inclusion:

  • patients between 40 - 100 years.
  • No improvement despite nonsurgical treatment for more than 3 months.
  • No history of lumbar fusion surgery.
  • Single or double-level lumbar foraminal stenosis with corresponding leg pain

Exclusion:

  • Severe neurological deficit (motor grade less than Grade III)
  • Combined inflammatory joint disease
  • Combined neurodegenerative disease such as Parkinson's disease or dementia * Combined cancer, traumatic fracture
  • Marked spinal deformity (C7 sagittal vertical axis > 10cm)

Treatment and study plan

lumbar foraminal decompression

Procedure

lumbar foraminal decompression with endoscopic instruments.

Fusion surgery

Procedure

Fusion surgery for patients with foraminal stenosis

Primary outcomes

  1. Cost-effectiveness

    Time frame: preoperation

    cost to increased one quality adjusted life year (QALY) after surgical treatment

  2. Cost-effectiveness

    Time frame: postoperative 6 months

    cost to increased one quality adjusted life year (QALY) after surgical treatment

  3. Cost-effectiveness

    Time frame: postoperative 1 year

    cost to increased one quality adjusted life year (QALY) after surgical treatment

  4. Cost-effectiveness

    Time frame: postoperative 2 years

    cost to increased one quality adjusted life year (QALY) after surgical treatment

Secondary outcomes

  1. Oswestry disability index (ODI)

    Time frame: preoperation

    ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.

  2. Oswestry disability index (ODI)

    Time frame: postoperative 6 months

    ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.

  3. Oswestry disability index (ODI)

    Time frame: postoperative 1 year

    ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.

  4. Oswestry disability index (ODI)

    Time frame: postoperative 2 years

    ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.

  5. Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)

    Time frame: preoperation

    NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.

    Numeric rating scale (NRS)

    : Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.

  6. Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)

    Time frame: postoperative 6 months

    NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.

    Numeric rating scale (NRS)

    : Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.

  7. Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)

    Time frame: postoperative 1 year

    NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.

    Numeric rating scale (NRS)

    : Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.

  8. Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)

    Time frame: postoperative 2 years.

    NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.

    Numeric rating scale (NRS)

    : Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Cost-effectiveness Analysis Between Lumbar Foraminotomy and Lumbar Single or Double Levels Fusion Surgery in Patients With Foraminal Stenosis

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2021
Registry last updated
Mar 15, 2024

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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