Rotator Cuff Tear ArthropathyNCT04645329
Immobilization in Reverse Shoulder Prosthesis
A study testing shoulder immovilization sling in people with Rotator Cuff Tear Arthropathy, run by Hospital del Mar at 1 site in Spain.
Trial summary
Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- shoulder immovilization sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Apr 2024
- Phase
- Interventional
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy.
- age between 65-85 a.
- without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis, ...)
- acceptance to be part of the study.
Who cannot join
- prosthetic surgery prior to the affected limb.
- other indications of reverse prosthesis other than rotator cuff arthropathies (acute fractures, sequelae fractures, tumor surgery, prosthetic revision surgeries).
- no acceptance to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Carlos Torrens, MD, PhD, 0034933674201, 86925@parcdesalutmar.cat
About this study
Official title: Should Patients Undergoing Reverse Shoulder Prostheses Due to Arthropathy of the Rotator Cuff be Immobilized? Randomized Prospective Study
Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- shoulder immovilization sling
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder immovilization slingDevice
immobilization of the arm after surgery
| Study group | Role | What they receive |
|---|---|---|
| group I (no immobilization) | Experimental | patients will be allowed to freely use their arm without any immobilization after surgery Receives: Device: shoulder immovilization sling |
| group II (3-week immobilization) | Active comparator | patients will be kept in an immobilization device for three weeks after surgery Receives: Device: shoulder immovilization sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain control (visual analogical scale)
determination of pain control between groups at different time points with the aid of a visual analogical scale of 10 points, where 0 means no pain and 10 means maximum pain.
Measured: determination of pain the day of the surgery, and then 24hours, 48hours, 7 days, 3-weeks, 3 months, 6 months, 1 year, 2 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Jan 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 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 Tear ArthropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective study. (computer-generated randomization list and saved in opaque envelopes)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
- Investigators
- Carlos Torrens, MD, PhD, Principal investigator, Chief Clinic of Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645329
- Sponsor's protocol ID
- 2019/8752/I
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Patients Undergoing Reverse Shoulder Prostheses Due to Arthropathy of the Rotator Cuff be Immobilized? Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04645329
- Acronym / sponsor ID
- 2019/8752/I
- Conditions
- Rotator Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 27 Nov 2020 (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.
Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized prospective study. (computer-generated randomization list and saved in opaque envelopes)
| Arm | Type | Receives |
|---|---|---|
| group I (no immobilization) | Experimental | Device: shoulder immovilization slingpatients will be allowed to freely use their arm without any immobilization after surgery |
| group II (3-week immobilization) | Active comparator | Device: shoulder immovilization slingpatients will be kept in an immobilization device for three weeks after surgery |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy.
- age between 65-85 a.
- without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis, ...)
- acceptance to be part of the study.
Key exclusion criteria (3 listed)
- prosthetic surgery prior to the affected limb.
- other indications of reverse prosthesis other than rotator cuff arthropathies (acute fractures, sequelae fractures, tumor surgery, prosthetic revision surgeries).
- no acceptance to participate in the study.
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 |
|---|---|---|
| shoulder immovilization slingimmobilization of the arm after surgery | Device | group I (no immobilization), group II (3-week immobilization) |
Primary outcome
Change in Pain control (visual analogical scale)
Time frame: determination of pain the day of the surgery, and then 24hours, 48hours, 7 days, 3-weeks, 3 months, 6 months, 1 year, 2 years postoperatively.
determination of pain control between groups at different time points with the aid of a visual analogical scale of 10 points, where 0 means no pain and 10 means maximum pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Carlos Torrens, MD, PhD principal investigator
Chief Clinic of Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shoulder immovilization sling in people with Rotator Cuff Tear Arthropathy, run by Hospital del Mar at 1 site 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 4 inclusion and 3 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 31 Mar 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Torrens, MD, PhD (0034933674201, 86925@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain control (visual analogical scale) (time frame: determination of pain the day of the surgery, and then 24hours, 48hours, 7 days, 3-weeks, 3 months, 6 months, 1 year, 2 years postoperatively.). 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 31 Mar 2022.