Gold Against Pains From Osteoarthrosis in the Knee
March 28, 2014 updated by: Northern Orthopaedic Division, Denmark
Clinical Effects From Implants of Gold Around the Arthrotic Knee Joint. A Randomized, Double Blind, Placebo Controlled Investigation.
Gold implantation around arthritic joints is a very popular treatment - but the effect has never been controlled.
Study Overview
Detailed Description
Randomization between
- Gold (4 x 3 berlocks, injected under local anesthesia) and
- Sham operation - only local anesthesia Functional and pain measures reported through the next 6 months.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Northern Jutland
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Frederikshavn, Northern Jutland, Denmark
- Northern Orthopaedic Division, Klinik Frederikshavn
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Arthrosis in knee joint
Exclusion Criteria:
Need for NSAID
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
VAS
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
WOMAC
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mogens B Laursen, MD, PhD, Northern Orthopaedic Division
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
September 19, 2006
First Submitted That Met QC Criteria
September 19, 2006
First Posted (Estimate)
September 20, 2006
Study Record Updates
Last Update Posted (Estimate)
March 31, 2014
Last Update Submitted That Met QC Criteria
March 28, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ON-04-015-MBL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.