Rotator Cuff TendinitisKalklavageNCT05264935
Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff
An observational study of Rotator Cuff Tendinitis and Ultrasonography, Interventional, run by Schulthess Klinik at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tendinitis, Ultrasonography, Interventional, Ultrasonography, Doppler, Color
- What is being tested?
- Ultrasound-Guided Puncture and Lavage (UGPL)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Schulthess Klinik
Zurich, 8008
Stefan Diermayr, Dr, Stefan.Diermayr@kws.ch
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound-Guided Puncture and Lavage (UGPL)
- Keywords
- calcific deposit, ultrasound-guided puncture and lavage, power doppler ultrasound
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Puncture and Lavage (UGPL)Procedure or surgery
After local anaesthesia with rapidocain the calcific deposit of the rotator cuff will be punctured and washed out with saline solution.
What is being measured
The primary outcome is the main question the study is designed to answer.
PDUS signal intensity
Power doppler ultrasonography (PDUS) signal intensity
Measured: One year after intervention
Secondary outcomes (8)
Residual calcific material
Residual calcific material (constant, decreasing, increasing)
Measured: 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
Measured: 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
Measured: One year after intervention
Constant Murley Score (CMS)
Constant Murley Score (CMS) from 0 (worse) to 100 (better) points
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: One year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 May 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264935
- Sponsor's protocol ID
- OE-0164
- Acronym
- Kalklavage
- Status last verified
- Jul 2023
- First submitted
- 8 Feb 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff: The Role of Power Doppler Sonography
- ClinicalTrials.gov ID
- NCT05264935
- Acronym / sponsor ID
- Kalklavage / OE-0164
- Keywords
- calcific deposit, ultrasound-guided puncture and lavage, power doppler ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | – |
Primary outcome
PDUS signal intensity
Time frame: One year after intervention
Power doppler ultrasonography (PDUS) signal intensity
8 secondary outcomes
Residual calcific material
Time frame: One year after intervention
Tendon rupture
Time frame: One year after intervention
Pain level
Time frame: One year after intervention
Constant Murley Score (CMS)
Time frame: One year after intervention
Shoulder function parameters
Time frame: One year after intervention
Shoulder function parameters
Time frame: One year after intervention
Subjective shoulder value (SSV)
Time frame: One year after intervention
Level of improvement
Time frame: One year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tendinitis and Ultrasonography, Interventional, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Audigé, Prof (+41443857580, forschung.oe@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDUS signal intensity (time frame: One year after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.