Status:
RECRUITING
Activity Levels Amongst Patients with Lumbar Spinal Stenosis
Lead Sponsor:
Region Zealand
Collaborating Sponsors:
Region Syddanmark
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
65+ years
Brief Summary
Lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, with symptoms including low back pain which worsens with ambulation, poor balance, decreased activity...
Detailed Description
Disease background: While lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, there is no universally accepted definition of LSS, and no accepted radiol...
Eligibility Criteria
Inclusion
- Age ≥ 65 years
- Referred to decompressive spinal surgery due to symptomatic lumbar spinal stenosis at ≥ 1 level
- Central canal LSS grade B or C (Schizas classification) at ≥ 1 level by Magnetic Resonance Imaging
- Minimum of 3 months of unsuccessful non-operative treatment
Exclusion
- Signs of malignancy or infection in the spinal column
- Severe comorbidities incl. neurodegenerative conditions which may contribute to balance problems
- Revision surgery (previous decompression surgery at the same vertebral level)
- Spinal surgery up to 1 year prior to the date of inclusion
- Mini Mental State Exam (MMSE) score of ≤ 27 points
- Degenerative spondylolisthesis more than 3mm on pre-operative imaging diagnostics
Key Trial Info
Start Date :
September 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06057428
Start Date
September 21 2023
End Date
April 1 2028
Last Update
November 14 2024
Active Locations (2)
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1
Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge
Køge, Denmark, 4600
2
Rygcenter Syddanmark, Middelfart Sygehus
Middelfart, Denmark, 5500