Investigating activity levels in elderly patients with lumbar spinal stenosis after surgery
Activity Levels Amongst Elderly Patients with Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery
Region Zealand · NCT06057428
This study looks at how surgery for lumbar spinal stenosis affects the activity levels of elderly patients aged 65 and older before and after the procedure over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Region Zealand (other) |
| Locations | 2 sites (Køge and 1 other locations) |
| Trial ID | NCT06057428 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on elderly patients aged 65 and older who are referred for decompressive surgery due to symptomatic lumbar spinal stenosis. It aims to objectively measure the effects of this surgical intervention on patients' activity levels before and after the procedure, as well as at regular intervals over a two-year period. The study addresses a gap in existing research by providing quantitative data on how surgery impacts physical activity, which is often subjectively reported. Participants will be monitored for changes in their activity levels to better understand the benefits of surgical treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who have been diagnosed with symptomatic lumbar spinal stenosis and have not responded to conservative treatment.
Not a fit: Patients with severe comorbidities, signs of malignancy or infection, or those who have had previous spinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how decompressive surgery improves activity levels and quality of life for patients with lumbar spinal stenosis.
How similar studies have performed: While many studies have explored surgical outcomes in terms of pain relief and quality of life, this specific focus on objective activity levels post-surgery is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Køge and 1 other locations
- Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge — Køge, Denmark (NOT_YET_RECRUITING)
- Rygcenter Syddanmark, Middelfart Sygehus — Middelfart, Denmark (RECRUITING)
Study contacts
- Principal investigator: Oliver B Zielinski, MD — Orthopaedic Department, Zealand University Hospital
- Study coordinator: Oliver B Zielinski, MD
- Email: ozi@regionsjaelland.dk
- Phone: +4593931049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spinal Stenosis, Spinal stenosis, Elderly, Activity, Surgery