Gold Against Pains From Osteoarthrosis in the Knee

This study has been withdrawn prior to enrollment.
(Withdrawn because of lack of approvement from local medical authorities)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: March 28, 2014
Last verified: March 2014
  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
Study Completion Date: October 2012
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 28, 2014
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 July 31, 2014