What is the cost-effectiveness of referral to MRI compared to usual care by the general practitioner in patients with persistent traumatic knee complaints.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are self reported knee related daily function (Lysholm),
health care and productivity costs (PRODISQ/TIC-P), and quality of life
(EuroQol) over a 12 months follow-up period (measured at 0, 1*, 3, 6, 9, 12
months).
Secondary outcome
Secondary outcomes are patient related health gain measured with function
(KOOS), severity of knee pain (NRS) and perceived recovery and satisfaction
with management by patient and general practitioner.
Background summary
General practitioners are regularly consulted by patients with traumatic knee
complaints. The Dutch clinical guideline *traumatic knee complaints* for
general practitioners at present does not recommend referral to MRI, because
the efficacy is of an MRI in primary care for patients with traumatic knee
complaints is still unknown. Direct referral to MRI might be a valuable tool
for general practitioners in making appropriate and informed decisions,
depending on whether it improves patient outcomes, reduces costs and affects
subsequent diagnosis and management.
Study objective
What is the cost-effectiveness of referral to MRI compared to usual care by the
general practitioner in patients with persistent traumatic knee complaints.
Study design
A multi-centre, open labeled randomized controlled noninferiority trial in
combination with a concurrent observational cohort study.
Intervention
Participating patients will be randomized into two groups;
1) MRI group; the patients will be referred for MRI of the knee by the general
practitioner, or 2) Usual care group; the patients will receive care conform
the Dutch general practitioners* clinical guideline and will not receive an MRI
referral by the general practitioner.
Study burden and risks
There are no risks associated with participation. The only tests that are used
are questionnaires, which will take about 30 minutes to fill in every 3 months.
Altogether this will take the patient 3 hours over a period of 1 year. The
questionnaires that are used are not associated with physical and physiological
discomfort. There are no benefits associated with participation, because the
efficacy is of an MRI in primary care for patients with traumatic knee
complaints is still unknown.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
Patients will be eligible for inclusion if they:
- (re)consulted their general practitioner with knee complaints (persistent pain and/or disability) due to trauma or sudden onset in the preceding six months and
- are aged 18 to 45 years.
Exclusion criteria
Patients will be excluded if:
- there is an indication for direct referral to an orthopaedic surgeon such as suspicion of fracture and/or an acute locked knee,
- the knee complaints due to trauma are already treated in secondary care,
- the patient is already known with osteoarthritis in the affected knee, other non- traumatic arthropathy, isolated patello-femoral joint pain or patella luxation,
- there is a previous MRI examination within the same episode of knee complaints,
- there is a previous surgical intervention on the same knee, and
- there are contra-indications for the use of MRI (claustrophobia, pregnancy, metal implants or a pacemaker).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40296.078.12 |