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

Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff: The Role of Power Doppler Sonography

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tendinitis; Ultrasonography, Interventional; Ultrasonography, Doppler, Color
• Intervention / Treatment: Procedure: Ultrasound-Guided Puncture and Lavage (UGPL)

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Laurent Audigé, Prof; Phone Number: +41443857580; Email: forschung.oe@kws.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Recruiting
    • Schulthess Klinik
    • Contact: Stefan Diermayr, Dr; Email: Stefan.Diermayr@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDUS signal intensity	Power doppler ultrasonography (PDUS) signal intensity	One year after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual calcific material	Residual calcific material (constant, decreasing, increasing)	One year after intervention
Tendon rupture	Follow up sonography will be performed to assess the occurrence of tendon rupture, which will be classified as complete, transmural or non transmural	One year after intervention
Pain level	Pain Scale Numeric Rating Scale from 0 (no pain) to 15 (worse pain) as part of the Constant Score	One year after intervention
Constant Murley Score (CMS)	Constant Murley Score (CMS) from 0 (worse) to 100 (better) points	One year after intervention
Shoulder function parameters	Shoulder range of motion (ROM) parameters in degree including elevation (flexion), abduction, and external rotation by 0° abduction measured with a standard goniometter	One year after intervention
Shoulder function parameters	Shoulder strength in 90° abduction position (measured also for the opposite shoulder)(Kg) measured with a spring balance.	One year after intervention
Subjective shoulder value (SSV)	Subjective shoulder value (SSV) is a patient-reported subjective outcome assessing on a scale from 0% (worse) to 100% (best) of normal shoulder condition	One year after intervention
Level of improvement	Patients are reporting separately if the improvement / shoulder status regarding pain, function and quality of life is acceptable (Yes/No) or not for them.	One year after intervention

Collaborators and Investigators

• Sponsor: Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: calcific deposit; ultrasound-guided puncture and lavage; power doppler ultrasound
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: OE-0164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No