Condition category
Musculoskeletal Diseases
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
02/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A C A Marijnissen

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology
F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 9758
a.c.a.marijnissen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Joint distraction is a relatively new approach in the treatment of severe Osteoarthritis (OA). Clinical efficacy has been proven for hip and ankle OA.

Hypothesis:
A two month distraction period results in similar clinical beneficial effects as a three month distraction period.

Ethics approval

Approval received from the Medical Ethical Committee of the University Medical Centre Utrecht on the 28th July 2004.

Study design

Non-randomised, non-controlled, interventional clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis

Intervention

Joint distraction applies temporary (two months) relief of mechanical wear and tear of the articular cartilage surfaces forming a joint. Nutrition of the cartilage is maintained due to intra-articular fluid pressure changes during treatment. Additionally subchondral sclerosis is diminished, diminishing mechanical stresses on the cartilage after treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain (according to the The Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])

Secondary outcome measures

Functional disability (according to the WOMAC)

Overall trial start date

28/07/2004

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age less than 55 years
2. Osteoarthritis, primary in the tibio-femoral joint, uni or bilateral
3. Severe osteoarthritis considered for joint replacement surgery/osteotomy

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

3

Participant exclusion criteria

1. Osteoarthritis in both knees
2. Primary retro-patellar osteoarthritis
3. Deviation of the mechanical axis greater than 10 º (independent of cartilage damage)
4. Primary intra-articular inflammation
5. Psychological problems, not allowing two months distraction

Recruitment start date

28/07/2004

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Rheumatology and Clinical Immunology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Charity

Funder name

Dutch Arthritis Association (Reumafonds) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes