Influence of Oxidative Dysbalance on Secondary Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01228487
Recruitment Status : Unknown
Verified July 2011 by Heinrich-Heine University, Duesseldorf.
Recruitment status was:  Recruiting
First Posted : October 26, 2010
Last Update Posted : July 26, 2011
Information provided by:
Heinrich-Heine University, Duesseldorf

Brief Summary:

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.

Condition or disease

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 : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Biomechanical Factors of Secondary Osteoarthritis: Oxidative and Nitrosative Stress as Predictive Factors of Joint Destruction
Study Start Date : October 2010
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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

Biospecimen Retention:   Samples Without DNA
Arthroscopical obtained wash- out preparations of synovial space Synovial biopsies Blood serum samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University clinic, patients, residents of Düsseldorf, Germany and surrounding cities

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01228487

Contact: Christoph Ziskoven, MD 004917622900349

Orthopedic Department, Heinrich-Heine University Medical School Recruiting
Düsseldorf, NRW, Germany, D40225
Contact: Christoph Ziskoven, MD    004917622900348   
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf

Responsible Party: Prof. Dr. med. R. Krauspe, Head of Orthopaedic Department, Heinrich-Heine University, Duesseldorf Identifier: NCT01228487     History of Changes
Other Study ID Numbers: ORTH-OA-1
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Heinrich-Heine University, Duesseldorf:
Oxidative Dysbalance
Oxidative Stress

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases