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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01611441
First received: May 31, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Osteoarthritis of the Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) . ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers in synovial fluid, synovial membrane, and cartilage. [ Time Frame: Day 1 (surgery). ] [ Designated as safety issue: No ]
  • Biomarkers in blood and urine. [ Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery). ] [ Designated as safety issue: No ]
  • Biomarkers by Magnetic Resonance Imaging (MRI). [ Time Frame: 1-5 days prior to day 1 (surgery). ] [ Designated as safety issue: No ]
  • Polymorphisms in 10 specific genes. [ Time Frame: 3-20 days prior to day 1 (surgery) or at any time in the study. ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

    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.



Biospecimen Retention:   Samples With DNA

Whole blood, plasma, serum, urine, synovial fluid, synovial membrane, cartilage


Enrollment: 125
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with osteoarthritis of the knee
Patients with osteoarthritis of the knee undergoing total knee replacement surgery.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary and secondary care clinics

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611441

Locations
Canada
Research Site
Montreal, Canada
Research Center
Newmarket, Canada
Research Site
Quebec, Canada
Sweden
Research Site
Kungalv, Sweden
Research Site
Motala, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rolf Karlsten, MD, PHD AstraZeneca R&D Sodertalje, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01611441     History of Changes
Other Study ID Numbers: D2285M00029, D2285M00029
Study First Received: May 31, 2012
Last Updated: June 26, 2012
Health Authority: Sweden: Regional Ethical Review Board
Canada: Research Ethics Boards at each clinic

Keywords provided by AstraZeneca:
Osteoarthritis of the knee
Biomarkers

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013