The effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee

ISRCTN	ISRCTN02328576
DOI	https://doi.org/10.1186/ISRCTN02328576
Protocol serial number	HTA 03/48/01
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 08/06/2006
Registration date: 09/06/2006
Last edited: 11/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marion Campbell
Scientific

Health Services Research Unit
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone	+44 (0)1224 554480
Email	m.k.campbell@abdn.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	KORAL
Study objectives	This is a pilot study, the design of which has been informed by extensive qualitative feasibility work, to assess in two UK centres (Aberdeen and North Staffordshire) the feasibility of mounting a multicentre, placebo-controlled trial to evaluate the effectiveness of arthoscopic lavage for osteoarthritis of the knee. Please note that, as of 11/05/2009, the anticipated end date has been updated from 30/06/2010 to 31/10/2008. Protocol V2 dated July 2006 is available on http://www.hta.ac.uk/protocols/200300480001.pdf
Ethics approval(s)	Application submitted to MREC, Scotland as of 09/06/06
Health condition(s) or problem(s) studied	Osteoarthritis of the knee
Intervention	1. Arthroscopic lavage (+/- debridement as deemed clinically necessary) 2. Placebo arthroscopic lavage 3. Non-operative management with specialist re-assessment
Intervention type	Other
Primary outcome measure(s)	1. To examine whether the trial processes as currently planned are appropriate, feasible and acceptable to patients, clinicians and the trial office staff 2. To quantify the throughput of eligible patients 3. To quantify the number of patients approached and the proportion of patients who would accept randomisation to the trial 4. To examine the acceptability of the trial information material to patients
Key secondary outcome measure(s)	The secondary research outcomes of the main trial (in which we anticipate the pilot patients' data being included) are: 1. General quality of life as measured by 12-item short form questionnaire (SF-12) 2. Patient utility as measured by EQ5D 3. Non-steroidal anti-inflammatory drug (NSAID) or analgesic use 4. Use of other treatments outside the trial interventions 5. Use and cost of health services 6. Cost-effectiveness - incremental cost per quality adjusted life year gained
Completion date	31/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	70
Key inclusion criteria	1. Adults (18 years or older) with radiological evidence of osteoarthritis (OA) of the knee who might routinely be considered for arthroscopic lavage 2. Fit for general anaesthetic (American Society of Anesthesiologists [ASA] grade 1 and 2) 3. Able to give informed consent
Key exclusion criteria	1. Patients for whom the orthopaedic surgeon judges that arthroscopic lavage is clearly indicated 2. Patients for whom arthroplasty is clearly indicated 3. Clear contraindication to general anaesthesia 4. Inability to fill in follow-up questionnaires
Date of first enrolment	01/07/2005
Date of final enrolment	31/10/2008

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Health Services Research Unit

Aberdeen
AB25 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/02/2011		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes