Clinical trial NCT01611441: Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement
Official title: Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis of the knee
Biomarkers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary and secondary care clinics

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

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
timeFrame: 3-20 days prior to day 1 (surgery) and day 1 (surgery) .
Secondary outcomes:
measure: Biomarkers in synovial fluid, synovial membrane, and cartilage.
timeFrame: Day 1 (surgery).
measure: Biomarkers in blood and urine.
timeFrame: 3-20 days prior to day 1 (surgery) and day 1 (surgery).
measure: Biomarkers by Magnetic Resonance Imaging (MRI).
timeFrame: 1-5 days prior to day 1 (surgery).
measure: Polymorphisms in 10 specific genes.
timeFrame: 3-20 days prior to day 1 (surgery) or at any time in the study.
measure: WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables.
timeFrame: 3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Research Site
city: Newmarket
country: Canada
facility: Research Center
city: Quebec
country: Canada
facility: Research Site
city: Kungalv
country: Sweden
facility: Research Site
city: Motala
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Sodertalje, Sweden
name: Rolf Karlsten, MD, PHD
role: STUDY_DIRECTOR
References:
citation: Radojcic MR, Thudium CS, Henriksen K, Tan K, Karlsten R, Dudley A, Chessell I, Karsdal MA, Bay-Jensen AC, Crema MD, Guermazi A. Biomarker of extracellular matrix remodelling C1M and proinflammatory cytokine interleukin 6 are related to synovitis and pain in end-stage knee osteoarthritis patients. Pain. 2017 Jul;158(7):1254-1263. doi: 10.1097/j.pain.0000000000000908.