Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement

AstraZeneca125 enrolled

Overview

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.

Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Osteoarthritis of the Knee

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (6)

Research Site

Montreal, Canada

Research Center

Newmarket, Canada

Research Site

Québec, Canada

Research Site

Kungälv, Sweden

Research Site

Motala, Sweden

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 in synovial fluid, synovial membrane, and cartilage.

Time frame: Day 1 (surgery).

Biomarkers in blood and urine.

Time frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery).

Biomarkers by Magnetic Resonance Imaging (MRI).

Time frame: 1-5 days prior to day 1 (surgery).

Polymorphisms in 10 specific genes.

Time frame: 3-20 days prior to day 1 (surgery) or at any time in the study.

WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables.

WOMAC consists of 3 subscales with a total of 24 questions regarding pain, stiffness and difficulty in performing daily activities. A VAS (Visual Analogue Scale) will be used for the patient to report the severity of the symptoms on the target knee. Endpoints are marked "No pain" (0 mm) and " Extreme pain" (100 mm) on a paper PRO (Patient Reported Outcome) questionnaire. The less pain scored the better outcome. NPQ accesses 12 different pain intensities. 0 represents no intensity and 100 represents worst intensity imaginable. The less intensity the better outcome.

Time frame: 3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.