Joint distraction in the treatment of knee osteoarthritis: efficacy and underlying mechanisms

ISRCTN	ISRCTN92846059
DOI	https://doi.org/10.1186/ISRCTN92846059
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A C A Marijnissen
Scientific

University Medical Centre Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology, F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 250 9758
Email	a.c.a.marijnissen@umcutrecht.nl

Study design	Non-randomised, non-controlled, interventional clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Other
Study type	Treatment
Scientific title	Joint distraction in the treatment of knee osteoarthritis: efficacy and underlying mechanisms
Study objectives	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(s)	Approval received from the Medical Ethical Committee of the University Medical Centre Utrecht on the 28th July 2004.
Health condition(s) or problem(s) studied	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
Primary outcome measure	Pain (according to the The Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])
Secondary outcome measures	Functional disability (according to the WOMAC)
Overall study start date	28/07/2004
Completion date	01/03/2010

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	3
Key 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
Key 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
Date of first enrolment	28/07/2004
Date of final enrolment	01/03/2010

University Medical Centre Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/04pp8hn57

Charity

Dutch Arthritis Association (Reumafonds) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		12/05/2011	20/08/2021	Yes	No

20/08/2021: Publication reference added.