Shoulder DiseaseNCT06092996
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
A study testing Time of Sling Use in people with Shoulder Disease and Rotator Cuff Tear Arthropathy, run by Duke University at 1 site in United States.
Trial summary
This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shoulder Disease, Rotator Cuff Tear Arthropathy, Shoulder Osteoarthritis
- What is being tested?
- Time of Sling Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to Dec 2028
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy
- Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis
- Rotator cuff arthropathy
- Glenohumeral arthritis
- Patient is between 18-100 years old
- Patient is English speaking
Who cannot join
- A history of ipsilateral shoulder arthroplasty
- A history of shoulder septic arthritis
- A history of a proximal humeral fracture
- Chronic locked dislocation
- Rheumatoid arthritis
- Tumors
Show all 14Show fewer
- Axillary nerve damage
- Non-functioning deltoid muscle
- Glenoid vault deficiency precluding baseplate fixation
- Infection and neuropathic joints
- Known or suspected non-compliance, drug or alcohol abuse
- Patients incapable of judgement or under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
- The subject is related to investigator as family members, employees, or other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Read the detailed description
The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study.
Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively.
Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.
- Being tested
- Time of Sling Use
- 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.
Time of Sling UseOther
Standard sling worn for only three days post operatively
| Study group | Role | What they receive |
|---|---|---|
| Sling | No intervention | Participants in the sling group will wear a sling according to current standard of care: 3 weeks postoperatively (2 weeks all the time, 3rd week at night and while in the community) |
| No Sling | Experimental | Participants in the no sling group will only wear a sling for three days postoperatively Receives: Other: Time of Sling Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop any kind of postoperative complication
Incidence of postoperative complications
Measured: 6 months primary, Up to the first 2 years following surgery
Secondary outcomes (2)
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: 6 months primary, Up to the first 2 years following surgery
Single Assessment Numeric Evaluation (SANE) score
The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function.
Measured: 6 months primary, Up to the first 2 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start7 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oke A Anakwenze, MD, MBA, Principal investigator, Duke UniversityChristopher Klifto, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092996
- Sponsor's protocol ID
- Pro00113901
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2023
- Last updated
- 8 Jan 2026
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sling vs No Sling After Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06092996
- Acronym / sponsor ID
- Pro00113901
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Oct 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.
This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Detailed description
The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study.
Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively.
Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sling | No intervention | –Participants in the sling group will wear a sling according to current standard of care: 3 weeks postoperatively (2 weeks all the time, 3rd week at night and while in the community) |
| No Sling | Experimental | Other: Time of Sling UseParticipants in the no sling group will only wear a sling for three days postoperatively |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy
- Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis
- Rotator cuff arthropathy
- Glenohumeral arthritis
Key exclusion criteria (14 listed)
- A history of ipsilateral shoulder arthroplasty
- A history of shoulder septic arthritis
- A history of a proximal humeral fracture
- Chronic locked dislocation
- Rheumatoid arthritis
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 |
|---|---|---|
| Time of Sling UseStandard sling worn for only three days post operatively | Other | No Sling |
Primary outcome
Number of participants who develop any kind of postoperative complication
Time frame: 6 months primary, Up to the first 2 years following surgery
Incidence of postoperative complications
2 secondary outcomes
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score
Time frame: 6 months primary, Up to the first 2 years following surgery
Single Assessment Numeric Evaluation (SANE) score
Time frame: 6 months primary, Up to the first 2 years following 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 8 Jan 2026.
- 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.
Oke A Anakwenze, MD, MBA principal investigator
Duke University
Christopher Klifto, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time of Sling Use in people with Shoulder Disease and Rotator Cuff Tear Arthropathy, run by Duke University 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 7 inclusion and 14 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 8 Jan 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?
Number of participants who develop any kind of postoperative complication (time frame: 6 months primary, Up to the first 2 years following 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 8 Jan 2026.