OsteoarthritisNCT01228487
Influence of Oxidative Dysbalance on Secondary Osteoarthritis
An observational study of Osteoarthritis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University clinic, patients, residents of Düsseldorf, Germany and surrounding cities
Who may be able to join
- Planned knee joint arthroscopy
- No history of trauma
Who cannot join
- Neoplasia
- Rheumatoid arthritis
- Intake of Steroids, cytostatic drugs,immunosuppression
- Pregnancy or lactation
- Addiction
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Orthopedic Department, Heinrich-Heine University Medical School
Düsseldorf, North Rhine-Westphalia, D40225
Christoph Ziskoven, MD, 004917622900348, christoph.ziskoven@med.uni-duesseldorf.de
About this study
Official title: 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.
Read the 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
- Keywords
- Oxidative Dysbalance, Oxidative Stress, Biomarker
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2012 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228487
- Sponsor's protocol ID
- ORTH-OA-1
- Status last verified
- Jul 2011
- First submitted
- 25 Oct 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Factors of Secondary Osteoarthritis: Oxidative and Nitrosative Stress as Predictive Factors of Joint Destruction
- ClinicalTrials.gov ID
- NCT01228487
- Acronym / sponsor ID
- ORTH-OA-1
- Conditions
- Osteoarthritis
- Keywords
- Oxidative Dysbalance, Oxidative Stress, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University clinic, patients, residents of Düsseldorf, Germany and surrounding cities
Key inclusion criteria (2 listed)
- Planned knee joint arthroscopy
- No history of trauma
Key exclusion criteria (6 listed)
- Neoplasia
- Rheumatoid arthritis
- Intake of Steroids, cytostatic drugs,immunosuppression
- Pregnancy or lactation
- Addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Ziskoven, MD (004917622900349, christoph.ziskoven@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.