Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
02/09/2009
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 Stirling Bryan

ORCID ID

Contact details

Health Services Management Centre
University of Birmingham
Park House
40 Edgbaston Park Road
Birmingham
B15 2RT
United Kingdom
+44 (0)121 414 4706
s.bryan@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/26/16

Study information

Scientific title

Acronym

Study hypothesis

This study considered the role of Magnetic Resonance Imaging (MRI) in the diagnosis of knee injuries in a District General Hospital (DGH) setting. The principal objective was to identify whether the use of MRI had a major impact on the clinical management of patients presenting with chronic knee problems, in whom surgery was being considered, whether it reduced overall costs and whether it improved patient outcome.

In addition, the research:
1. Explored the 'diagnostic accuracy' of initial clinical investigation of the knee by an orthopaedic trainee, consultant knee specialist and consultant radiologist
2. Considered the variability and diagnostic accuracy of interpretations of knee MRI investigations between radiologists
3. Measured the strength of preference for the potential diagnostic/therapeutic impact of knee MRI (i.e. the avoidance of surgery)

Ethics approval

Not provided at time of registration

Study design

Single centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Musculoskeletal injury

Intervention

The research was based on a single-centre randomised controlled trial conducted at Kent and Canterbury Hospital.

Patients were randomised to:
1. Investigation using an MRI scan (MRI trial arm), or
2. Investigation using arthroscopy (no-MRI trial arm)

Investigation of diagnostic accuracy:
For the investigation of diagnostic accuracy of initial clinical investigation, the sample comprised 114 patients recruited in a separate study conducted at St Thomas’ Hospital. The sample was drawn from patients presenting at the Accident and emergency Department with an acute knee injury. All study patients received an MRI scan, but initial diagnosis was made without access to the scan or the radiologist’s report. After 12 months, all clinical notes and MRI scans of study patients were reviewed and a final ‘reference standard’ diagnosis for each patient was reached. Comparison was made between the diagnosis recorded by each clinician (i.e. orthopaedic trainee, knee specialist and consultant radiologist) and the reference diagnosis.

Investigation of the generalisability of results:
For this substudy, the MRI images from 80 patients (recruited at St Thomas’ Hospital) were interpreted independently by seven consultant radiologists at DGHs and the St Thomas’ Hospital MRI radiologist. For each area of the knee, the level of agreement (measured using weighted kappa) between the responses of the eight radiologists and the reference standard diagnosis was assessed.

Investigation of preferences:
The investigation of potential patient preferences for the diagnostic/therapeutic impact of MRI was explored using a discrete choice conjoint measurement research design. Choices involved selecting between two alternative scenarios described using four attributes, and data were collected from 585 undergraduate sports science students and analysed using a random-effects probit model.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The study investigated the benefits of knee MRI at two levels:
1. Diagnostic/therapeutic impact (i.e. avoidance of surgery)
2. Patient outcome (using the 36-item Short Form questionnaire [SF-36] and the EuroQoL quality-of-life measurement instruments [EQ-5D]); quality of life was assessed at baseline and at 6 and 12 months

Costs were assessed from the perspectives of the NHS and patients. All analyses were by intention to treat.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/1996

Overall trial end date

31/12/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Patients attending with knee problems in whom surgery was being considered were recruited from routine orthopaedic clinics.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

118

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/01/1996

Recruitment end date

31/12/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Management Centre
Birmingham
B15 2RT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
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

2001 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11532240
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15209182

Publication citations

  1. HTA monograph

    Bryan S, Weatherburn G, Bungay H, Hatrick C, Salas C, Parry D, Field S, Heatley F, The cost-effectiveness of magnetic resonance imaging for investigation of the knee joint., Health Technol Assess, 2001, 5, 27, 1-95.

  2. Results

    Bryan S, Bungay HP, Weatherburn G, Field S, Magnetic resonance imaging for investigation of the knee joint: a clinical and economic evaluation., Int J Technol Assess Health Care, 2004, 20, 2, 222-229.

Additional files

Editorial Notes