NCT01228487

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

2.1 years

First QC Date

October 25, 2010

Last Update Submit

July 25, 2011

Conditions

Keywords

Oxidative DysbalanceOxidative StressBiomarker

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Planned knee joint arthroscopy
  • No history of trauma

You may not qualify if:

  • Neoplasia
  • Rheumatoid arthritis
  • Intake of Steroids, cytostatic drugs,immunosuppression
  • Pregnancy or lactation
  • Addiction
  • Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Department, Heinrich-Heine University Medical School

Düsseldorf, North Rhine-Westphalia, D40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Christoph Ziskoven, MD

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations