Efficacy of MRI in primary care for patients with knee complaints due to trauma

Efficacy of MRI in primary care for patients with knee complaints due to trauma - TACKLE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41300

Enrollment

360

Registered

2012-10-19

Start date

2012-11-14

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee compaints Knee injuries

Interventions

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.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)