Influence of Oxidative Dysbalance on Secondary Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Heinrich-Heine University, Duesseldorf.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01228487
First received: October 25, 2010
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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
Osteoarthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biomechanical Factors of Secondary Osteoarthritis: Oxidative and Nitrosative Stress as Predictive Factors of Joint Destruction

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Biospecimen Retention:   Samples Without DNA

Arthroscopical obtained wash- out preparations of synovial space Synovial biopsies Blood serum samples


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University clinic, patients, residents of Düsseldorf, Germany and surrounding cities

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228487

Contacts
Contact: Christoph Ziskoven, MD 004917622900349 christoph.ziskoven@yahoo.com

Locations
Germany
Orthopedic Department, Heinrich-Heine University Medical School Recruiting
Düsseldorf, NRW, Germany, D40225
Contact: Christoph Ziskoven, MD    004917622900348    christoph.ziskoven@med.uni-duesseldorf.de   
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
  More Information

No publications provided

Responsible Party: Prof. Dr. med. R. Krauspe, Head of Orthopaedic Department, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01228487     History of Changes
Other Study ID Numbers: ORTH-OA-1
Study First Received: October 25, 2010
Last Updated: July 25, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014