Gold Against Pains From Osteoarthrosis in the Knee | NCT00378339

Studies
Gold Against Pains From Osteoarthrosis in the Knee

NCT00378339

Sponsor

Northern Orthopaedic Division, Denmark

Status

Withdrawn

Last Update Posted

Mar 31, 2014Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Arthritis

Interventions

gold berlocks

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn because of lack of approvement from local medical authorities

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Sep 19, 2006

First Submission Date that Met QC Criteria

Sep 19, 2006

First Posted Date

Sep 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2014

Last Update Posted Date

Mar 31, 2014Estimated

Name	Class
University of Aarhus	OTHER
Aarhus University Hospital	OTHER

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
gold berlocks	Device

Measure	Description	Time Frame
VAS

Measure	Description	Time Frame
WOMAC

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Arthrosis in knee joint

Exclusion Criteria:

Need for NSAID

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mogens B Laursen, MD, Phd	Northern Orthopaedic Division	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Klinik Frederikshavn		Frederikshavn	Northern Jutland		Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided