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

Status

Withdrawn

Conditions

Intervention / Treatment

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

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

  • Denmark
    • Northern Jutland
      • Frederikshavn, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Frederikshavn

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.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Aarhus University Hospital
University of Aarhus

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

Keywords

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.

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