Gold Against Pains From Osteoarthrosis in the Knee - Full Text View

Gold Against Pains From Osteoarthrosis in the Knee

This study is not yet open for participant recruitment.
Verified by Northern Orthopaedic Division, Denmark, August 2008

Sponsors and Collaborators:	Northern Orthopaedic Division, Denmark University of Aarhus Aarhus University Hospital
Information provided by:	Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:	NCT00378339

Purpose

Goldimplantation around arthritic joints is a very popular treatment - but the effect has never been controlled.

Condition	Intervention	Phase
Arthritis	Device: gold berlocks	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Clinical Effects From Implants of Gold Around the Artrotic Knee Joint. A Randomized, Doubbelblind, Placebocontrolled Investigation.

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:

Secondary Outcome Measures:

WOMAC

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Detailed Description:

Randomization between

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

arthrosis in knee joint

Exclusion Criteria:

need for NSAID

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378339

Contacts


Contact: Mogens B Laursen, MD, Phd		mogens.berg.laursen@rn.dk

Locations


Denmark, Northern Jutland
	Northern Orthopaedic Division, Klinik Frederikshavn	Not yet recruiting
	Frederikshavn, Northern Jutland, Denmark

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

University of Aarhus

Aarhus University Hospital

Investigators


Principal Investigator:	Mogens B Laursen, MD, Phd	Northern Orthopaedic Division

More Information

Study ID Numbers:	ON-04-015-MBL
First Received:	September 19, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00378339
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:

arthrosis

gold

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoarthritis

Arthritis

Joint Diseases

Pain

ClinicalTrials.gov processed this record on October 17, 2008