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

June 26, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Research Site
      • Newmarket, Canada
        • Research Center
      • Quebec, Canada
        • Research Site
  • Sweden
      • Kungalv, Sweden
        • Research Site
      • Motala, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary and secondary care clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with osteoarthritis of the knee
Patients with osteoarthritis of the knee undergoing total knee replacement surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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) .
3-20 days prior to day 1 (surgery) and day 1 (surgery) .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers in synovial fluid, synovial membrane, and cartilage.
Time Frame: Day 1 (surgery).
Day 1 (surgery).
Biomarkers in blood and urine.
Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery).
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).
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.
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.
Time Frame: 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.
3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Rolf Karlsten, MD, PHD, AstraZeneca R&D Sodertalje, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2285M00029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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