Influence of Oxidative Dysbalance on Secondary Osteoarthritis

NCT ID: NCT01228487

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Osteoarthritis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Chronic knee pain

Clinical manifestation of knee joint OA, radiological and arthroscopic III° or more. n=20

No interventions assigned to this group

Control group

Patients coming for post- primary repair of the cruciate ligament, having no inflammation and no sign of OA. n=10

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Heinrich-Heine University, Duesseldorf

Locations

Orthopedic Department, Heinrich-Heine University Medical School

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christoph Ziskoven, MD

Role: CONTACT

christoph.ziskoven@yahoo.com

004917622900349

Facility Contacts

Christoph Ziskoven, MD

Role: primary

christoph.ziskoven@med.uni-duesseldorf.de

004917622900348

Other Identifiers

ORTH-OA-1

Identifier Type: -

Identifier Source: org_study_id