- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01228487
Influence of Oxidative Dysbalance on Secondary Osteoarthritis
Biomechanical Factors of Secondary Osteoarthritis: Oxidative and Nitrosative Stress as Predictive Factors of Joint Destruction
The important role of mechanical joint stress for the insert and progress of osteoarthritis (OA) is supported by recent studies. The degeneration of joint cartilage is caused either by unphysiological load of a healthy joint or physiological load of a damaged joint. The exact mechanisms leading from increased weight bearing and overuse to cartilage degeneration are mostly unknown.
The hypothesis of the study is that parameters of oxidative stress in the joint synovial space reflect damages possibly leading to OA. These parameters correlate with parameters of oxidative stress in the peripheral blood. Aim of the study is the identification of such non- invasive obtainable biomarkers which represent the degenerative and regenerative changes in joint.
Study Overview
Status
Conditions
Detailed Description
Patients with clinically manifest OA typically consult the physician at time of irreversible cartilage destruction. This is due to the long time clinically silent progress of the disease. A biomarker screening profile for joint damage is a valuable tool for the detection of over use and joint damaging conditions especially in competitive sports. This would provide a method for OA risk assessment for the patient before clinical symptoms occur. For this the first step is the identification of biological substances reflecting pathologic changes in the joint.
Since preterm chondrocyte senescence, apoptosis and ageing related changes are key factors in OA pathophysiology and each of these factors is closely related to oxidative dysbalance the measurement of these factors and correlation with the amount of joint damage is promising.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christoph Ziskoven, MD
- Phone Number: 004917622900349
- Email: christoph.ziskoven@yahoo.com
Study Locations
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NRW
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Düsseldorf, NRW, Germany, D40225
- Recruiting
- Orthopedic Department, Heinrich-Heine University Medical School
-
Contact:
- Christoph Ziskoven, MD
- Phone Number: 004917622900348
- Email: christoph.ziskoven@med.uni-duesseldorf.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Planned knee joint arthroscopy
- No history of trauma
Exclusion Criteria:
- Neoplasia
- Rheumatoid arthritis
- Intake of Steroids, cytostatic drugs,immunosuppression
- Pregnancy or lactation
- Addiction
- Participation in other clinical trials
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Acute knee pain
Patients with a history of knee pain < 6 months.
The radiologic and arthroscopic OA stadium is less or equal II°.
n=20.
|
Chronic knee pain
Clinical manifestation of knee joint OA, radiological and arthroscopic III° or more.
n=20
|
Control group
Patients coming for post- primary repair of the cruciate ligament, having no inflammation and no sign of OA. n=10
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTH-OA-1
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.
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