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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611441
• Other study ID #: D2285M00029
• Secondary ID: D2285M00029
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 26, 2012
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardCanada: Research Ethics Boards at each clinic
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Canada	Research Site	Montreal
Canada	Research Center	Newmarket
Canada	Research Site	Quebec
Sweden	Research Site	Kungalv
Sweden	Research Site	Motala
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	No
Secondary	Biomarkers in synovial fluid, synovial membrane, and cartilage.		Day 1 (surgery).	No
Secondary	Biomarkers in blood and urine.		3-20 days prior to day 1 (surgery) and day 1 (surgery).	No
Secondary	Biomarkers by Magnetic Resonance Imaging (MRI).		1-5 days prior to day 1 (surgery).	No
Secondary	Polymorphisms in 10 specific genes.		3-20 days prior to day 1 (surgery) or at any time in the study.	No
Secondary	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.	3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).	No