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

Completed

• Conditions: Osteoarthritis of the Knee

• Registration Number: NCT01611441
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-05-31
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.	3-20 days prior to day 1 (surgery) and day 1 (surgery) .

Secondary Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (2)

Research Site; 🇸🇪 Stockholm, Sweden

Research Center; 🇨🇦 Newmarket, Canada