ArthritisPhase 2NCT00378339
Gold Against Pains From Osteoarthrosis in the Knee
A Phase 2 study testing gold berlocks in people with Arthritis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Gold implantation around arthritic joints is a very popular treatment - but the effect has never been controlled. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis
- What is being tested?
- gold berlocks
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthrosis in knee joint
Who cannot join
- Need for NSAID
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Klinik Frederikshavn
Frederikshavn, Northern Jutland
About this study
Official title: 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.
Read the detailed description
Randomization between
- Gold (4 x 3 berlocks, injected under local anesthesia) and
- Sham operation - only local anesthesia Functional and pain measures reported through the next 6 months.
- Conditions
- Arthritis
- Being tested
- gold berlocks
- Keywords
- arthrosis, gold
- Medical subject headings
- Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gold berlocksDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Secondary outcomes (1)
WOMAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Withdrawn because of lack of approvement from local medical authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Mogens B Laursen, MD, Phd, Principal investigator, Northern Orthopaedic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378339
- Sponsor's protocol ID
- ON-04-015-MBL
- Status last verified
- Mar 2014
- First submitted
- 19 Sep 2006
- Last updated
- 31 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects From Implants of Gold Around the Arthrotic Knee Joint. A Randomized, Double Blind, Placebo Controlled Investigation.
- ClinicalTrials.gov ID
- NCT00378339
- Acronym / sponsor ID
- ON-04-015-MBL
- Conditions
- Arthritis
- Keywords
- arthrosis, gold
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn because of lack of approvement from local medical authorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gold implantation around arthritic joints is a very popular treatment - but the effect has never been controlled.
Detailed description
Randomization between
- Gold (4 x 3 berlocks, injected under local anesthesia) and
- Sham operation - only local anesthesia Functional and pain measures reported through the next 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Arthrosis in knee joint
Key exclusion criteria (1 listed)
- Need for NSAID
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gold berlocks | Device | – |
Primary outcome
VAS
1 secondary outcome
WOMAC
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mogens B Laursen, MD, Phd principal investigator
Northern Orthopaedic Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gold berlocks in people with Arthritis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.