Investigating activity levels in elderly patients with lumbar spinal stenosis after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rygcenter Syddanmark, Middelfart Sygehus
  Middelfart, Denmark Recruiting
• Ortopædkirurgisk afdeling, Sjællands Universitetshospital Køge
  Køge, Denmark Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.