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Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff (Kalklavage)

S

Schulthess Klinik

Status

Enrolling

Conditions

Ultrasonography, Doppler, Color
Rotator Cuff Tendinitis
Ultrasonography, Interventional

Treatments

Procedure: Ultrasound-Guided Puncture and Lavage (UGPL)

Study type

Observational

Funder types

Other

Identifiers

NCT05264935
OE-0164

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Laurent Audigé, Prof

Data sourced from clinicaltrials.gov

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