Condition category
Musculoskeletal Diseases
Date applied
08/06/2006
Date assigned
09/06/2006
Last edited
11/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.charttrials.abdn.ac.uk/

Contact information

Type

Scientific

Primary contact

Prof Marion Campbell

ORCID ID

Contact details

Health Services Research Unit
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 554480
m.k.campbell@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/48/01

Study information

Scientific title

Acronym

KORAL

Study hypothesis

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

Application submitted to MREC, Scotland as of 09/06/06

Study design

Pilot, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/07/2005

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 70

Participant 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

Recruitment start date

01/07/2005

Recruitment end date

31/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research Unit
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21338481

Publication citations

  1. Results

    Campbell MK, Entwistle VA, Cuthbertson BH, Skea ZC, Sutherland AG, McDonald AM, Norrie JD, Carlson RV, Bridgman S, , Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility., Trials, 2011, 12, 50, doi: 10.1186/1745-6215-12-50.

Additional files

Editorial Notes