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Gold Against Pains From Osteoarthrosis in the Knee

This study has been withdrawn prior to enrollment.
(Withdrawn because of lack of aprovement from local medical authorities)
Sponsor:
Collaborators:
University of Aarhus
Aarhus University Hospital
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00378339
First received: September 19, 2006
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Arthritis
 Device: gold berlocks
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Effects From Implants of Gold Around the Arthrotic Knee Joint. A Randomized, Double Blind, Placebo Controlled Investigation.

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

Primary Outcome Measures:
  • VAS

Secondary Outcome Measures:
  • WOMAC

Enrollment: 0
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

  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.
  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

Locations
Denmark
Northern Orthopaedic Division, Klinik Frederikshavn
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

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00378339     History of Changes
Other Study ID Numbers: ON-04-015-MBL
Study First Received: September 19, 2006
Last Updated: October 17, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
arthrosis
gold

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013