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Completed

NCT Number: NCT01611441

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Montreal, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Biomarkers in synovial fluid, synovial membrane, and cartilage.

    Time frame: Day 1 (surgery).

  2. Biomarkers in blood and urine.

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

  3. Biomarkers by Magnetic Resonance Imaging (MRI).

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

  4. Polymorphisms in 10 specific genes.

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

  5. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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