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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01611441

Enrollment

125

Registered

2012-06-05

Start date

2011-12-31

Completion date

2012-06-30

Last updated

2012-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis of the knee, Biomarkers

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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) .

Secondary

Measure	Time frame	Description
Biomarkers in synovial fluid, synovial membrane, and cartilage.	Day 1 (surgery).	—
Biomarkers in blood and urine.	3-20 days prior to day 1 (surgery) and day 1 (surgery).	—
Biomarkers by Magnetic Resonance Imaging (MRI).	1-5 days prior to day 1 (surgery).	—
Polymorphisms in 10 specific genes.	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.	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.

Countries

Canada, Sweden

Outcome results