- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611441
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Director: Rolf Karlsten, MD, PHD, AstraZeneca R&D Sodertalje, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Osteoarthritis of the Knee
-
Taiwan Liposome CompanyCompletedOSTEOARTHRITIS OF THE KNEETaiwan, United States
-
University Hospital, GhentCompletedOsteoarthritis of the Knee JointBelgium
-
Bone Therapeutics S.ANordic Bioscience A/SCompletedSymptomatic Osteoarthritis of the KneeDenmark, Belgium, United Kingdom, Czechia, Hong Kong, Moldova, Republic of, Poland
-
Rush University Medical CenterWithdrawnSymptomatic Osteoarthritis of the Knee
-
Region SkaneRecruitingOsteoarthritis of the Knee or HipSweden
-
UMC UtrechtCompletedMedial Compartment Osteoarthritis of the KneeNetherlands
-
Massachusetts General HospitalGöteborg University; Seoul National University Hospital; Ulsan University Hospital and other collaboratorsUnknownOsteoarthritis of the Knee | Traumatic Arthritis of the KneeUnited States
-
Ampio Pharmaceuticals. Inc.TerminatedSevere Osteoarthritis of the KneeUnited States
-
Hospital General de Jerez de la FronteraZiekenhuis Oost-LimburgCompletedPainful Osteoarthritis of the KneeSpain
-
Ampio Pharmaceuticals. Inc.TerminatedSevere Osteoarthritis of the KneeUnited States