Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT01618435
Eligibility Criteria:
Inclusion Criteria:
* Spinal stenosis, olisthesis grade 1-2 (\>3 mm), facet joint arthrosis and flavus hypertrophia verified by a mr-scan and x-ray including maximally 2 levels ranging from L1-S1.
* A score of 6 and more on Konno´s "History of Examination Characteristic".
* Signed informed content.
Exclusion Criteria:
* Any disease demanding obligate thromboprophylaxis treatment, including mechanical valve, (DVT with cancer/thrombophilia, AMI, apoplexia cerebri, TCI, valve-operation)\< 3 months, coronar metal stent \< 6 weeks and coronar drug eluted/coated stent \< 12 months.
* Atrial fibrillation and one of the following: Mitral stenosis, valveprothesis and apoplexia cerebri/TCI.
* Atrial fibrillation and two of the following: Heart insufficient, HT, DM, age \> 75 years, EF \< 35 %.
* Known cancer in the axial skeleton.
* Ongoing chemotherapy.
* Fracture i the lower back within a year prior to inclusion.
* Reduced distance of walking due to non-spinal related causes.
* Candidate for more than two-level intervention.
* Dementia assessed by the MMSE
* ASA 3+4
* Age below 60 years.
* Missed 3 months of conservative treatment without success
* The use of steroids and bisphosphonates.
* Prior radiotherapy to the lower back.
* Haematologic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01618435
Study Brief:
Protocol Section:
NCT01618435