Clinical trial NCT05264935: Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff
Official title: Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff: The Role of Power Doppler Sonography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tendinitis
Ultrasonography, Interventional
Ultrasonography, Doppler, Color
Keywords: calcific deposit
ultrasound-guided puncture and lavage
power doppler ultrasound
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with calcific deposit within the rotator cuff of a minimum size of 1.0 x 0.5 x 0.4cm (length x width x depth) and without clear signs of resorption.

Brief summary: The primary goal of the study is to assess ultrasonographic Power Doppler signals after ultrasound-guided puncture and lavage of rotator cuff calcific tendinitis of the shoulder. Secondary outcomes are sonographic features like the course of residual calcific material and the course of tendon healing als well as the clinical symptoms of the patient.

Detailed description: In our study we investigate the intensity of the power doppler signal after ultrasound-guided puncture and lavage (UGPL) of the rotator cuff calcific tendinitis. We assume that UGPL will lead to intratendinous neovascularisation and that the amount of retrieved calcific material is associated with the PDUS signal. The measurement of the signal will be performed in pre determined time slot for 12 months. Additional we study the correlation between the PDUS signal and the clinical symptoms of the patient and the healing process.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years and older
* Pain in the deltoid region worsening with activities above shoulder level and/or at night with a calcific deposit
* Ultrasound evaluation of the calcific deposit with type I or II characteristics, a solitary conformation, a minimum size of 1.0 x 0.5 x 0.4cm (length x width x depth) and without clear signs of resorption (PDUS grade 0 - I°, see study procedure).
* In case of multiple calcific deposits, it has to be warranted that the other deposits are smaller than the minimum size of 1.0 x 0.5 x 0.4cm and with no signs of PDUS signals.
* Qualification for more intensive treatment on account of no clinical improvement after a minimum of 3 months with conservative treatment (physical therapy and oral anti-inflammatory drugs).
* able to understand the content of the patient information / consent form in German and give consent to take part in the project

Exclusion Criteria:

* Previous UGPL or surgery of the affected shoulder
* Treatment with subacromial injection (SAI) or ESWT in the three months before inclusion
* Other causes of shoulder complaints (e.g. rotator cuff tear, frozen shoulder, inflammatory arthritis, bursitis, ...)
* Intervention failure (no retrieval of calcific material, leakage of the injected saline, disruption of the calcific rim or distribution of calcific material)
* Patients with a language barrier hindering questionnaire completion
* Pregnancy

Primary outcomes:
measure: PDUS signal intensity
timeFrame: One year after intervention
Secondary outcomes:
measure: Residual calcific material
timeFrame: One year after intervention
measure: Tendon rupture
timeFrame: One year after intervention
measure: Pain level
timeFrame: One year after intervention
measure: Constant Murley Score (CMS)
timeFrame: One year after intervention
measure: Shoulder function parameters
timeFrame: One year after intervention
measure: Shoulder function parameters
timeFrame: One year after intervention
measure: Subjective shoulder value (SSV)
timeFrame: One year after intervention
measure: Level of improvement
timeFrame: One year after intervention
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References: