Rotator Cuff TearNCT07851233
Patient Education and Sling Use After Shoulder Surgery
A study testing Intervention - Living with a Sling Educational Pamphlets in people with Rotator Cuff Tear and Sling, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear, Sling, Shoulder Pain
- What is being tested?
- Intervention - Living with a Sling Educational Pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 30 Nov 2026
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants scheduled to undergo shoulder surgery at Rothman Orthopaedics that requires more than 1 week of postoperative shoulder sling use.
- Participants who are able to provide informed consent.
- Participants who have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
Who cannot join
- Participants undergoing shoulder surgery that does not require more than 1 week of postoperative shoulder sling use.
- Participants who do not have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Evaluation of Educational Pamphlets and Female Patient Experience With Post-operative Sling-Wear
This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. The study will also examine whether following sling-use instructions is associated with better short-term recovery and patient-reported outcomes for up to 6 months after surgery.
- Conditions
- Rotator Cuff Tear, Sling, Shoulder Pain
- Being tested
- Control - Standard Postoperative Education, Intervention - Living with a Sling Educational Pamphlets
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - Standard Postoperative EducationBehavioural
Participants will receive the standard postoperative education and instructions provided by their treating orthopedic physician for patients undergoing shoulder surgery requiring postoperative sling use.
Intervention - Living with a Sling Educational PamphletsBehavioural
Participants will receive standard postoperative education plus educational pamphlets providing guidance on performing daily activities while wearing a shoulder sling. The pamphlets address personal hygiene, household tasks, and self-care. Female participants will also receive a pamphlet addressing female-specific self-care.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Standard postoperative education | Active comparator | Standard postoperative education Receives: Behavioral: Control - Standard Postoperative Education |
| Pamphlet Intervention Group | Active comparator | Standard postoperative education + "Living with a Sling" educational pamphlets Receives: Behavioral: Intervention - Living with a Sling Educational Pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sling adherence
Sling adherence will be assessed using patient-reported survey responses regarding adherence to prescribed shoulder sling use during the postoperative period.
Measured: 4 to 6 weeks after surgery
Secondary outcomes (1)
Patient-reported shoulder function
Shoulder function will be assessed using the American Shoulder and Elbow Surgeons (ASES) score.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Bishop, MD, Rothman Institute Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851233
- Sponsor's protocol ID
- MBIS2024-1306
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Educational Pamphlets and Female Patient Experience With Post-operative Sling-Wear
- ClinicalTrials.gov ID
- NCT07851233
- Acronym / sponsor ID
- MBIS2024-1306
- Conditions
- Rotator Cuff Tear, Sling, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Oct 2026 (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.
This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. The study will also examine whether following sling-use instructions is associated with better short-term recovery and patient-reported outcomes for up to 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Standard postoperative education | Active comparator | Behavioral: Control - Standard Postoperative EducationStandard postoperative education |
| Pamphlet Intervention Group | Active comparator | Behavioral: Intervention - Living with a Sling Educational PamphletsStandard postoperative education + "Living with a Sling" educational pamphlets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants scheduled to undergo shoulder surgery at Rothman Orthopaedics that requires more than 1 week of postoperative shoulder sling use.
- Participants who are able to provide informed consent.
- Participants who have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
Key exclusion criteria (2 listed)
- Participants undergoing shoulder surgery that does not require more than 1 week of postoperative shoulder sling use.
- Participants who do not have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
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 |
|---|---|---|
| Control - Standard Postoperative EducationParticipants will receive the standard postoperative education and instructions provided by their treating orthopedic physician for patients undergoing shoulder surgery requiring postoperative sling use. | Behavioural | Control Group - Standard postoperative education |
| Intervention - Living with a Sling Educational PamphletsParticipants will receive standard postoperative education plus educational pamphlets providing guidance on performing daily activities while wearing a shoulder sling. The pamphlets address personal hygiene, household tasks, and self-care. Female participants will also receive a pamphlet addressing female-specific self-care. | Behavioural | Pamphlet Intervention Group |
Primary outcome
Sling adherence
Time frame: 4 to 6 weeks after surgery
Sling adherence will be assessed using patient-reported survey responses regarding adherence to prescribed shoulder sling use during the postoperative period.
1 secondary outcome
Patient-reported shoulder function
Time frame: 6 months after surgery
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 1 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention - Living with a Sling Educational Pamphlets in people with Rotator Cuff Tear and Sling, run by Rothman Institute Orthopaedics at 1 site in United States.
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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. 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 United States. 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?
Sling adherence (time frame: 4 to 6 weeks after surgery). 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 1 Oct 2026.