Massive Rotator Cuff TearsNCT05780229
Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.
An observational study of Massive Rotator Cuff Tears and Shoulder Disease, run by Parc de Salut Mar at 6 sites in Spain.
Trial summary
The purpose of this study is: 1) to identify relevant treatment outcomes for people with massive rotator cuff tears of the shoulder joint, according to the experience of the affected people, to facilitate treatment shared decision-making during the specialist consultation in Spain; 2) to compare the effectiveness of… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Massive Rotator Cuff Tears, Shoulder Disease
- What is being tested?
- Conservative treatment, Arthroscopic Decompression Surgery and Reverse Prosthesis
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 200 participants
- Where
- 6 sitesSpain
- Study dates
- 27 Mar 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with massive rotator cuff tears.
Who may be able to join
- Age between 65 and 85 years.
- No previous surgical treatment in the affected shoulder.
- Complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging;
Who cannot join
- Neurological injury.
- Active infection.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
Barcelona, 08003
Hospital del Mar
Barcelona, 08003
Hospital Clínic
Barcelona, 08036
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208
About this study
Official title: Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
The purpose of this study is: 1) to identify relevant treatment outcomes for people with massive rotator cuff tears of the shoulder joint, according to the experience of the affected people, to facilitate treatment shared decision-making during the specialist consultation in Spain; 2) to compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.
Read the detailed description
Primary Objectives:
Phase 1 (Qualitative):
- To explore the perceptions, believes, experiences and coping strategies that are relevant results for people undergoing treatment of massive rotator cuff tears.
- To identify the relevant outcomes for people with massive rotator cuff tears, and their experiences with the shared-decision making process.
Phase 2 (Quantitative):
- To compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.
Outline:
Phase 1:
A qualitative, interpretative, descriptive study with a hermeneutics phenomenological approach was conducted from an 'etic' (from phonetic) perspective. Through hermeneutical phenomenology it was intended to describe and understand the multiple meanings that people with massive rotator cuff tears give to their experience and the results they expect from their treatment. A theoretical sampling of maximum variation was carried out using a segmentation criterion, being the evaluation before or after the treatment in those patients who attended the visit of the specialist in Spain.
Phase 2:
This is a prospective observational study of a cohort with rotator massive cuff tears treated either with conservative treatment, arthroscopic decompressive surgery, or reverse prosthesis.
Participants were consecutively recruited in 5 Spanish hospital departments (located in two autonomous communities). Patients eligible for inclusion were: age 65-85 years, without previous surgical treatment in the affected shoulder, and complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging. Patients were excluded if they have a neurological injury and/or an active infection.
Demographic and clinical characteristics at baseline are recorded at clinical sites and in the interview pretreatment, and include birthdate, sex, intervention, date of intervention, date of rehabilitation, chronic conditions, smoking status, employment status, and a question about the relevant outcome identified through the Phase 1.
Quality of Life questionnaires are administered centrally by telephone interviews before treatment and during follow-up at 6, 12 and 24 months after treatment. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Oxford Shoulder Score (OSS); and (2) the EuroQol-5 Dimension (EQ-5D-5L).
The sample size calculated to detect differences between groups (0.07 points in the EQ-5D-5L utility index, minimal important difference) was of 200 patients considering the three treatment groups, given a statistical power of at least 80% at a significance level of 5%, and lost to follow-up of 10%.
- Conditions
- Massive Rotator Cuff Tears, Shoulder Disease
- Being tested
- Conservative treatment, Arthroscopic Decompression Surgery, Reverse Prosthesis, Pain-Relief Medication, Reverse Prosthesis Device
- Keywords
- Mixed metholodgy, Massive Rotator Cuff Tears, Shoulder Disease, Comparative Effectiveness Research, Prosthesis, Arthroscopic Surgery, Conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentProcedure or surgery
Also called Rehabilitation
The rehabilitation is based on restoring the balance of the shoulder joint. Aiming to diminish pain and restore function, pain control and inflammation are addressed during the firsts 3-6 weeks. Before week 3, pendulum movements are allowed to initiate mobilization of the shoulder joint. Aiming to gain (almost) complete shoulder joint mobility, a passive and active mobility exercise program is carried out. Lastly, the focus is on muscle reinforcement, performing a series of active exercises with weights or bands to exercise different muscles of the shoulder or the shoulder girdle.
Arthroscopic Decompression SurgeryProcedure or surgery
Arthroscopic decompression surgery of the rotator cuff tear consists of cleaning the subacromial space. The procedures that are sometimes performed to diminish pain may include, removing the inflamed bursa, releasing the long head of the biceps (if injured), or lightly burring the acromion bone under which the tendons slide.
Reverse ProsthesisProcedure or surgery
The reverse prosthesis consists of shoulder articular joint replacement. The humeral head is sectioned, and, on the scapular side, a metal tray is placed, which is fixed with screws, and a metal half-sphere fixed to the metal tray. On the humeral side, a metal stem with a concave plastic component is placed to articulate with the metal half-sphere, allowing shoulder mobility without the need of rotator cuff muscles.
Pain-Relief MedicationDrug
In the reverse prosthesis procedure and arthroscopic decompression surgery, the pain-relief medication plan is a standard regimen for all patients, which can be modified as needed. This plan is based on 50mg of dexketoprofeno, 1g of paracetamol, and 100mg of tramadol.
Reverse Prosthesis DeviceDevice
In the reverse prosthesis procedure, a Delta III reverse shoulder prosthesis is applied. The original design was developed by Grammont in 1980's, and has 2 components: 1) a metal tray fixed with screws, and a metal half-sphere fixed to the metal tray, and 2) a concave polyethylene component.
| Study group | Role | What they receive |
|---|---|---|
| Massive Rotator Cuff Tears: Mixed Methodology | Phase 1: A theoretical sampling of maximum variation was carried out using a segmentation criterion, being the evaluation before or after the treatment in those patients who attended the visit in 5 Spanish hospitals.
Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals. Receives: Procedure: Conservative treatment; Procedure: Arthroscopic Decompression Surgery; Procedure: Reverse Prosthesis; Drug: Pain-Relief Medication; Device: Reverse Prosthesis Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevant treatment outcome identified through the Phase 1 of the study.
"Fend for yourself" was identified in the Qualitative Phase as a relevant outcome. It was captured through a question before treatment: "To what extent are you able to fend for yourself".
Measured: Before treatment
Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study).
"Fend for yourself" was identified in the Qualitative Phase as a relevant outcome, and was captured through two questions: A) "To what extent were you able to fend for yourself before the injury?"; and B) "To what extent can you fend for yourself after treatment?".
Measured: At 6, 12, and 24 months after treatment
Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments
The Oxford Shoulder Score (OSS) is a 12-item instrument assessing the impact of shoulder treatments and their outcomes. Response options for each OSS item are on a 4-level Likert scale, which ranges from 0 to 48, where higher scores indicate better outcomes.
Measured: Before and 6, 12, and 24 months after treatment
Secondary outcomes (2)
Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
The EuroQol-5D Dimensions (EQ-5D-5L) is a generic econometric instrument that contains five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity in each dimension. From the possible combinations of scales and severity levels (3125 health states), a utility index is obtained, which ranges from 1 (perfect health) to negative values, 0 being the value attributed to death.
Measured: Before and 6, 12, and 24 months after treatment
Ability to carry out normal daily activities measured with the Constant-Murley Score
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters, which define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: Before and 6, 12, and 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start27 Mar 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Massive Rotator Cuff TearsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Universitario Fundación Jiménez Díaz, Parc Taulí Hospital Universitari, Hospital Universitario La Paz
- Responsible party
- Sponsor
- Investigators
- Montse Ferrer Forés, MD, Ph.D., Principal investigator, IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.Carlos Torrens Cánovas, MD, Ph.D., Principal investigator, Hospital del Mar, 08003 Barcelona, Spain,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780229
- Sponsor's protocol ID
- PI18/00152
- Status last verified
- May 2025
- First submitted
- 21 Feb 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation. Data and associated documentation will be made available to users only under a data sharing agreement that provides for: * A commitment to use the data only for research purposes and not to identify any individual participant; * A commitment to protect data through the use of appropiate information technology; * A commitment to destroy or return the data after analyses are complete.
Publications
Barrufet C, Zamora V, Lizano-Barrantes C, Torrens C, Buron A, Calvo E, Peidro L, Miquel J, Barco R, Ferrer M. Relevant treatment outcomes for individuals aged 60 and older with massive rotator cuff tears: a qualitative study with 16 patients. Acta Orthop. 2025 Apr 14;96:322-330. doi: 10.2340/17453674.2025.43474.
PubMed 40223678
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treatments of Massive Tears in the Shoulder Rotator Cuff, Assessed With Relevant Results for the Patient: A Mixed Methodology Study.
- ClinicalTrials.gov ID
- NCT05780229
- Acronym / sponsor ID
- PI18/00152
- Conditions
- Massive Rotator Cuff Tears, Shoulder Disease
- Keywords
- Mixed metholodgy, Massive Rotator Cuff Tears, Shoulder Disease, Comparative Effectiveness Research, Prosthesis, Arthroscopic Surgery, Conservative treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Universitario Fundación Jiménez Díaz, Parc Taulí Hospital Universitari, Hospital Universitario La Paz
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2023 (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 purpose of this study is: 1) to identify relevant treatment outcomes for people with massive rotator cuff tears of the shoulder joint, according to the experience of the affected people, to facilitate treatment shared decision-making during the specialist consultation in Spain; 2) to compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.
Detailed description
Primary Objectives:
Phase 1 (Qualitative):
- To explore the perceptions, believes, experiences and coping strategies that are relevant results for people undergoing treatment of massive rotator cuff tears.
- To identify the relevant outcomes for people with massive rotator cuff tears, and their experiences with the shared-decision making process.
Phase 2 (Quantitative):
- To compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.
Outline:
Phase 1:
A qualitative, interpretative, descriptive study with a hermeneutics phenomenological approach was conducted from an 'etic' (from phonetic) perspective. Through hermeneutical phenomenology it was intended to describe and understand the multiple meanings that people with massive rotator cuff tears give to their experience and the results they expect from their treatment. A theoretical sampling of maximum variation was carried out using a segmentation criterion, being the evaluation before or after the treatment in those patients who attended the visit of the specialist in Spain.
Phase 2:
This is a prospective observational study of a cohort with rotator massive cuff tears treated either with conservative treatment, arthroscopic decompressive surgery, or reverse prosthesis.
Participants were consecutively recruited in 5 Spanish hospital departments (located in two autonomous communities). Patients eligible for inclusion were: age 65-85 years, without previous surgical treatment in the affected shoulder, and complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging. Patients were excluded if they have a neurological injury and/or an active infection.
Demographic and clinical characteristics at baseline are recorded at clinical sites and in the interview pretreatment, and include birthdate, sex, intervention, date of intervention, date of rehabilitation, chronic conditions, smoking status, employment status, and a question about the relevant outcome identified through the Phase 1.
Quality of Life questionnaires are administered centrally by telephone interviews before treatment and during follow-up at 6, 12 and 24 months after treatment. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Oxford Shoulder Score (OSS); and (2) the EuroQol-5 Dimension (EQ-5D-5L).
The sample size calculated to detect differences between groups (0.07 points in the EQ-5D-5L utility index, minimal important difference) was of 200 patients considering the three treatment groups, given a statistical power of at least 80% at a significance level of 5%, and lost to follow-up of 10%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Massive Rotator Cuff Tears: Mixed Methodology | – | Procedure: Conservative treatment, Procedure: Arthroscopic Decompression Surgery, Procedure: Reverse Prosthesis, Drug: Pain-Relief Medication, Device: Reverse Prosthesis DevicePhase 1: A theoretical sampling of maximum variation was carried out using a segmentation criterion, being the evaluation before or after the treatment in those patients who attended the visit in 5 Spanish hospitals. Phase 2: A consecutive sample of patients with massive rotator cuff tears, treated with conservative treatment, arthroscopy decompression surgery, or reverse prosthesis in 5 Spanish hospitals. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with massive rotator cuff tears.
Key inclusion criteria (3 listed)
- Age between 65 and 85 years.
- No previous surgical treatment in the affected shoulder.
- Complete rupture of the rotator cuff tendons, verified by magnetic resonance imaging;
Key exclusion criteria (2 listed)
- Neurological injury.
- Active infection.
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 |
|---|---|---|
| Conservative treatmentAlso: RehabilitationThe rehabilitation is based on restoring the balance of the shoulder joint. Aiming to diminish pain and restore function, pain control and inflammation are addressed during the firsts 3-6 weeks. Before week 3, pendulum movements are allowed to initiate mobilization of the shoulder joint. Aiming to gain (almost) complete shoulder joint mobility, a passive and active mobility exercise program is carried out. Lastly, the focus is on muscle reinforcement, performing a series of active exercises with weights or bands to exercise different muscles of the shoulder or the shoulder girdle. | Procedure or surgery | Massive Rotator Cuff Tears: Mixed Methodology |
| Arthroscopic Decompression SurgeryArthroscopic decompression surgery of the rotator cuff tear consists of cleaning the subacromial space. The procedures that are sometimes performed to diminish pain may include, removing the inflamed bursa, releasing the long head of the biceps (if injured), or lightly burring the acromion bone under which the tendons slide. | Procedure or surgery | Massive Rotator Cuff Tears: Mixed Methodology |
| Reverse ProsthesisThe reverse prosthesis consists of shoulder articular joint replacement. The humeral head is sectioned, and, on the scapular side, a metal tray is placed, which is fixed with screws, and a metal half-sphere fixed to the metal tray. On the humeral side, a metal stem with a concave plastic component is placed to articulate with the metal half-sphere, allowing shoulder mobility without the need of rotator cuff muscles. | Procedure or surgery | Massive Rotator Cuff Tears: Mixed Methodology |
| Pain-Relief MedicationIn the reverse prosthesis procedure and arthroscopic decompression surgery, the pain-relief medication plan is a standard regimen for all patients, which can be modified as needed. This plan is based on 50mg of dexketoprofeno, 1g of paracetamol, and 100mg of tramadol. | Drug | Massive Rotator Cuff Tears: Mixed Methodology |
| Reverse Prosthesis DeviceIn the reverse prosthesis procedure, a Delta III reverse shoulder prosthesis is applied. The original design was developed by Grammont in 1980's, and has 2 components: 1) a metal tray fixed with screws, and a metal half-sphere fixed to the metal tray, and 2) a concave polyethylene component. | Device | Massive Rotator Cuff Tears: Mixed Methodology |
Primary outcome
Relevant treatment outcome identified through the Phase 1 of the study.
Time frame: Before treatment
"Fend for yourself" was identified in the Qualitative Phase as a relevant outcome. It was captured through a question before treatment: "To what extent are you able to fend for yourself".
Change from baseline in relevant treatment outcome (identified through the Phase 1 of the study).
Time frame: At 6, 12, and 24 months after treatment
"Fend for yourself" was identified in the Qualitative Phase as a relevant outcome, and was captured through two questions: A) "To what extent were you able to fend for yourself before the injury?"; and B) "To what extent can you fend for yourself after treatment?".
Change in health-related quality of life measured with the Oxford Shoulder Score among shoulder treatments
Time frame: Before and 6, 12, and 24 months after treatment
The Oxford Shoulder Score (OSS) is a 12-item instrument assessing the impact of shoulder treatments and their outcomes. Response options for each OSS item are on a 4-level Likert scale, which ranges from 0 to 48, where higher scores indicate better outcomes.
2 secondary outcomes
Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
Time frame: Before and 6, 12, and 24 months after treatment
Ability to carry out normal daily activities measured with the Constant-Murley Score
Time frame: Before and 6, 12, and 24 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Results publication: PubMed 40223678Barrufet C, Zamora V, Lizano-Barrantes C, Torrens C, Buron A, Calvo E, Peidro L, Miquel J, Barco R, Ferrer M. Relevant treatment outcomes for individuals aged 60 and older with massive rotator cuff tears: a qualitative study with 16 patients. Acta Orthop. 2025 Apr 14;96:322-330. doi: 10.2340/17453674.2025.43474.
- Individual participant dataSharing planned: Yes. Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation. Data and associated documentation will be made available to users only under a data sharing agreement that provides for: * A commitment to use the data only for research purposes and not to identify any individual participant; * A commitment to protect data through the use of appropiate information technology; * A commitment to destroy or return the data after analyses are complete.
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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.
Montse Ferrer Forés, MD, Ph.D. principal investigator
IMIM-Hospital del Mar Medical Research Institute, 08003 Barcelona, Spain.
Carlos Torrens Cánovas, MD, Ph.D. principal investigator
Hospital del Mar, 08003 Barcelona, Spain,
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Massive Rotator Cuff Tears and Shoulder Disease, run by Parc de Salut Mar at 6 sites in Spain.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevant treatment outcome identified through the Phase 1 of the study. (time frame: Before treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780229, which also lists 1 linked publication.
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 3 Jun 2025.