Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

Rotator Cuff Tendinitis Clinical Trial

— Kalklavage  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264935
• Other study ID #: OE-0164
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2023
• Source: Schulthess Klinik
• Contact: Laurent Audigé, Prof
• Phone: +41443857580
• Email: forschung.oe[@]kws.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Tendinopathy
• Ultrasonography, Interventional

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDUS signal intensity	Power doppler ultrasonography (PDUS) signal intensity	One year after intervention
Secondary	Residual calcific material	Residual calcific material (constant, decreasing, increasing)	One year after intervention
Secondary	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
Secondary	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
Secondary	Constant Murley Score (CMS)	Constant Murley Score (CMS) from 0 (worse) to 100 (better) points	One year after intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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