Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

NCT ID: NCT05264935

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-04-01

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.

Conditions

Rotator Cuff Tendinitis; Ultrasonography, Interventional; Ultrasonography, Doppler, Color

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound-Guided Puncture and Lavage (UGPL)

After local anaesthesia with rapidocain the calcific deposit of the rotator cuff will be punctured and washed out with saline solution.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Schulthess Klinik

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Laurent Audigé, Prof

Role: CONTACT

forschung.oe@kws.ch

+41443857580

Facility Contacts

Stefan Diermayr, Dr

Role: primary

Stefan.Diermayr@kws.ch

Other Identifiers

OE-0164

Identifier Type: -

Identifier Source: org_study_id