Sling Use After Shoulder Surgery

Overseen By Caroline Questell, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Rheumatoid arthritis, Tumors, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best approach to using a sling (a device to support and immobilize the arm) after shoulder surgery, specifically reverse total shoulder replacement. Participants will split into two groups: one wears a sling for three weeks, while the other wears it for only three days. The aim is to determine which method aids recovery more effectively. This trial suits those scheduled for shoulder surgery due to conditions like rotator cuff issues or shoulder arthritis and who can follow post-surgery instructions. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance recovery methods for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that sling use after shoulder surgery is safe?

Research has shown that using a sling after shoulder surgery is generally safe. Studies indicate no significant difference in complications whether patients wear the sling for two weeks or six weeks. This suggests the sling itself doesn't cause many problems. For those considering joining a trial involving sling use after surgery, current evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether reducing sling use after shoulder surgery can be just as effective as the standard practice. Typically, patients wear slings for up to three weeks to aid recovery. However, this trial investigates if wearing a sling for only three days can suffice. If successful, this could mean less discomfort and faster mobility for patients, making recovery more comfortable and potentially quicker.

What evidence suggests that using a sling after shoulder surgery is effective?

This trial will compare using a sling to not using one after shoulder surgery. Research has shown that wearing a sling might not always aid recovery. Some studies found no significant difference in healing when comparing slings to other methods of immobilizing the shoulder. One study even suggested that not using a sling can lead to better outcomes, such as improved movement and function. Many patients reported difficulty sleeping and performing daily tasks while wearing a sling. Overall, considering the pros and cons of using a sling after surgery is important. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher Klifto, MD

Principal Investigator

Duke University

Oke Anakwenze, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-100 who are scheduled for a primary reverse shoulder arthroplasty at Duke University. They must live within 20 miles of RTP, be willing to attend physical therapy at Duke, and can fill out questionnaires and follow the study's visit schedule.

Inclusion Criteria

I have arthritis in my shoulder joint.

I am a candidate for shoulder replacement surgery due to my condition.

You are a native English speaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo reverse total shoulder arthroplasty and initial recovery with sling use as per group assignment

3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery with standard of care visits

2 years

Visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Sling

Trial Overview The study compares two post-surgery practices: one group will wear a sling for four weeks after shoulder replacement surgery, while the other will use it only until their nerve block wears off or up to three days post-surgery.

How Is the Trial Designed?

Group I: No Sling Experimental Treatment 1 Intervention

Participants in the no sling group will only wear a sling for three days postoperatively

Group II: Sling Active Control 1 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)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study of 36 patients undergoing total shoulder arthroplasty, using a neutral rotation sling led to significantly better outcomes in external rotation and pain relief compared to an internal rotation sling.

Patients with the neutral rotation sling experienced less night pain and greater improvements in shoulder mobility, indicating that this positioning may enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The position of sling immobilization influences the outcomes of anatomic total shoulder arthroplasty: a randomized, single-blind, prospective study. Baumgarten, KM., Osborn, R., Schweinle, WE., et al.[2019]

In a study of 960 patients who underwent reverse total shoulder arthroplasty, a two-week sling immobilization period showed no increase in postoperative complications compared to a six-week period, indicating that shorter immobilization is safe.

Both groups had similar rates of complications, including dislocations and infections, suggesting that patients may benefit from reduced immobilization time without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No difference in complications between two-week vs. six-week duration of sling immobilization after reverse total shoulder arthroplasty. Alben, MG., Gambhir, N., Kingery, MT., et al.[2023]

In a randomized controlled trial involving patients aged 18 to 75 with rotator cuff tears, both an abduction brace and an antirotation sling showed similar levels of postoperative pain and functional improvement up to one year after arthroscopic repair.

Neither the abduction brace nor the antirotation sling demonstrated a significant advantage in pain reduction or functional outcomes, suggesting that both methods are equally effective for postoperative shoulder immobilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abduction Brace Versus Antirotation Sling After Arthroscopic Cuff Repair: The Effects on Pain and Function. Hollman, F., Wolterbeek, N., Zijl, JAC., et al.[2018]

A survey of 499 surgeons revealed significant differences in post-operative sling use for shoulder surgeries between the US and Europe, with US surgeons favoring abduction pillow slings and longer immobilization durations compared to European surgeons.

Surgeons with more years of experience tended to recommend shorter sling durations after various shoulder procedures, indicating that clinical experience may influence post-operative care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoulder Surgery Postoperative Immobilization: An International Survey of Shoulder Surgeons. Freehill, MT., Murray, IR., Calvo, E., et al.[2023]

In a randomized controlled trial involving 60 young patients with first-time anterior shoulder dislocations, immobilization in external rotation did not significantly reduce the rate of recurrent instability compared to traditional internal rotation immobilization, with both groups showing similar rates of instability (37% vs. 40%).

Quality-of-life scores measured by the Western Ontario Shoulder Instability index (WOSI) and American Shoulder and Elbow Surgeons evaluation (ASES) showed no significant differences between the two immobilization methods, suggesting that external rotation may not provide additional benefits in functional outcomes after shoulder dislocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External rotation immobilization for primary shoulder dislocation: a randomized controlled trial. Whelan, DB., Litchfield, R., Wambolt, E., et al.[2022]

The study presents a straightforward technique for restraining the shoulder after injury or surgery, which may enhance patient comfort and recovery.

This method aims to provide effective immobilization, potentially improving healing outcomes for patients with shoulder injuries or post-operative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple shoulder restraint. Williamson, JB.[2019]

The study compares the effectiveness of an abduction brace versus a simple sling after arthroscopic rotator cuff repair, focusing on postoperative pain as the primary outcome measure.

Critics argue that using postoperative pain instead of long-term clinical outcomes as the primary measure may limit the study's conclusions, highlighting the need for more robust data on the long-term effectiveness of both treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting Back to Basics: The "Primary" Outcome Measure Determines a Study's Conclusion. Rossi, MJ., Brand, JC., Lubowitz, JH.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10395168/

Sling Versus Abduction Brace Shoulder Immobilization After ... However, recent studies have found no significant difference in clinical outcomes with postoperative shoulder immobilization using an abduction brace versus a ...

2. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(25)00263-4/fulltext

Shoulder Abduction Braces Are Unnecessary After Rotator ... In summary, it is my opinion that the available evidence from RCTs demonstrates no disadvantage to using a simple sling after posterosuperior ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666638325001409

Challenges with sling use following shoulder surgery 84.5% of patients had difficulty sleeping for an average of 6.5 weeks. 51.8% of patients needed help bathing, 47.5% of patients required help drying off, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7475399/

To sling or not to sling the shoulder after rotator cuff repair This study found that the absence of a sling was associated with better outcomes, including earlier mobility and better functional scores, than sling ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03488433?cond=Rotator%20Cuff%20Tear%20Arthropathy&rank=3

NCT03488433 | Abduction Brace Versus Antirotation Sling ... To compare the functional and anatomical outcomes, and patient satisfaction and compliance between two different postoperative immobilization methods ...

6. mdpi.com mdpi.com/2079-7737/12/2/291

Shoulder Surgery Postoperative Immobilization An abduction pillow sling was the preferred method of immobilization for the majority of US-based surgeons, following Bankart repair, Latarjet ...

7. withpower.com withpower.com/trial/phase-rotator-cuff-tear-arthropathy-10-2023-698d5

Sling Use After Shoulder Surgery Research shows that using a sling after shoulder surgery is generally safe, with no significant difference in complications whether used for two weeks or six ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4004123/

A CRITERION BASED SLING WEANING PROGRESSION ... Results: Patients completed sling weaning at an overall mean of 16.6 ± 5.0 days with continued use in unprotected military settings only beyond this timeframe.