CompletedNot Applicable

Outcomes of Patients With Foraminal Stenosis

South Korea52 participantsStarted 2021-08-22

Plain-language summary

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.

Who can participate

Age range40 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Cost-effectiveness

Timeframe: preoperation

Cost-effectiveness

Timeframe: postoperative 6 months

Cost-effectiveness

Timeframe: postoperative 1 year

Cost-effectiveness

Timeframe: postoperative 2 years

Trial details

NCT IDNCT05140733

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-28

View on ClinicalTrials.gov More Lumbar Foraminal Stenosis trials