Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- AstraZeneca
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.
Detailed Description
Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who will undergo a total knee replacement due to osteoarthritis.
- •Symptoms of the knee for at least 6 months prior to study start.
Exclusion Criteria
- •Key-hole surgery performed on target knee within 3 months prior to study start.
- •History of disorders in which part of the immune system is missing or defective.
Outcomes
Primary Outcomes
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery) .
Secondary Outcomes
- Biomarkers by Magnetic Resonance Imaging (MRI).(1-5 days prior to day 1 (surgery).)
- Polymorphisms in 10 specific genes.(3-20 days prior to day 1 (surgery) or at any time in the study.)
- Biomarkers in synovial fluid, synovial membrane, and cartilage.(Day 1 (surgery).)
- Biomarkers in blood and urine.(3-20 days prior to day 1 (surgery) and day 1 (surgery).)
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables.(3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).)