Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

NCT05264935 | Unknown

• 1 other identifier: OE-0164
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

calcific deposit; ultrasound-guided puncture and lavage; power doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• PDUS signal intensity

  Power doppler ultrasonography (PDUS) signal intensity

  One year after intervention

Secondary Outcomes (8)

• Residual calcific material

  One year after intervention

• Tendon rupture

  One year after intervention

• Pain level

  One year after intervention

• Constant Murley Score (CMS)

  One year after intervention

• Shoulder function parameters

  One year after intervention

Interventions

Ultrasound-Guided Puncture and Lavage (UGPL) PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Previous UGPL or surgery of the affected shoulder
• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Central Study Contacts

Laurent Audigé, Prof

CONTACT

+41443857580; forschung.oe@kws.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 3, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)