Gold Against Pains From Osteoarthrosis in the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378339
Recruitment Status : Withdrawn (Withdrawn because of lack of approvement from local medical authorities)
First Posted : September 20, 2006
Last Update Posted : March 31, 2014
University of Aarhus
Aarhus University Hospital
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:
Gold implantation around arthritic joints is a very popular treatment - but the effect has never been controlled.

Condition or disease Intervention/treatment Phase
Arthritis Device: gold berlocks Phase 2

Detailed Description:

Randomization between

  1. Gold (4 x 3 berlocks, injected under local anesthesia) and
  2. Sham operation - only local anesthesia Functional and pain measures reported through the next 6 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Effects From Implants of Gold Around the Arthrotic Knee Joint. A Randomized, Double Blind, Placebo Controlled Investigation.
Study Start Date : January 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. VAS

Secondary Outcome Measures :
  1. WOMAC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Arthrosis in knee joint

Exclusion Criteria:

Need for NSAID

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378339

Northern Orthopaedic Division, Klinik Frederikshavn
Frederikshavn, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
University of Aarhus
Aarhus University Hospital
Principal Investigator: Mogens B Laursen, MD, Phd Northern Orthopaedic Division

Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT00378339     History of Changes
Other Study ID Numbers: ON-04-015-MBL
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Northern Orthopaedic Division, Denmark: