Focused Ultrasound of the Popliteal Fossa for Detection of Symptomatic Baker's Cysts in Patients With Suspected Deep Vein Thrombosis: A Pilot Diagnostic Accuracy Study

ConditionBaker's Cyst
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

Quality improvement study with prospective observational design. The study explores the feasibility of testing diagnostic accuracy of an emergency department-performed focused ultrasound scan of the popliteal fossa in detecting symptomatic Baker's cysts, and to evaluate the potential for such follow-ups to conserve radiological resources. Ultimately, this work aims to establish the feasibility and provide the foundational data necessary for a future definitive diagnostic accuracy study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Clinical signs and symptoms of DVT, prompting the treating physician to initiate d-Dimer or CCUS diagnostic strategies

Disqualifiers

Prior inclusion

FUP performed following d-Dimer or CCUS result already revealed

Trial population

Adult patients referred to the Emergency Department at Aarhus University Hospital with suspected deep vein thrombosis and undergoing diagnostic evaluation with D-dimer testing and/or complete compression ultrasound of the lower extremity will be included consecutively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Index Test (Focused Ultrasound of the Popliteal Fossa)

    Diagnostic test

    Eligible patients will undergo a focused ultrasound examination of the popliteal fossa performed by a trained research assistant or emergency physician. The examination will be conducted before the results of D-dimer testing and CCUS are available. Operators will assess the presence and characteristics of Baker's cysts, evaluate whether an identified cyst is likely to explain the patient's presenting symptoms, estimate the probability of concurrent DVT, and complete a structured interpretation survey. FUP findings will be recorded for research purposes only and will not influence patient management.

  • Reference test (Routine DVT Diagnostic Pathway)

    Diagnostic test

    Following FUP, all participants will proceed through the routine diagnostic pathway for suspected DVT. Depending on clinical probability and D-dimer results, patients may undergo no further testing or radiologist-performed complete compression ultrasound of the lower extremity (CCUS) according to standard practice. Final diagnoses established through the routine diagnostic pathway will serve as the reference standard.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with suspected deep vein thrombosis (DVT)2 interventions

Trial outcomes

Primary outcomes

1

Participant recruitment rate

Number of eligible patients enrolled per study month and proportion of eligible patients successfully enrolled.

Time frame
Immediately after the procedure

Secondary outcomes

1

Completion rate of Focused Ultrasound of the Popliteal Fossa

Proportion of initiated FUP examinations successfully completed and deemed interpretable.

Time frame
Immediately after the procedure
2

Duration of the FUP examination

Time required to perform and document the FUP examination.

Time frame
Immediately after the procedure
3

Diagnostic accuracy of FUP for detection of symptomatic Baker's cysts

Sensitivity, specificity, positive predictive value, and negative predictive value of FUP compared with radiologist-performed complete compression ultrasound of the lower extremity (CCUS).

Time frame
Immediately after the procedure
4

Frequency of symptomatic Baker's cysts among patients evaluated for suspected DVT.

Proportion of participants with a symptomatic Baker's cyst identified on FUP.

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

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