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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Sling, Shoulder Abduction Immobilizer Sling, Arm Sling after shoulder surgery?

Research comparing different types of slings, like abduction braces and antirotation slings, after shoulder surgery shows that they can help manage pain and improve function in the short term. However, there is no clear consensus on the best type of sling or the optimal duration of use for long-term outcomes. ^{1 2 3 4 5}

Is sling use after shoulder surgery generally safe?

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 weeks after certain surgeries. ^{1 2 4 6 7}

How does sling use after shoulder surgery differ from other treatments?

Sling use after shoulder surgery is unique because there is no standard protocol for immobilization, and the position of the sling can influence recovery outcomes. Unlike other treatments, the effectiveness of sling use can vary based on the position of the arm, such as external rotation, which may reduce instability after certain shoulder injuries. ^{1 2 3 6 7}

Research Team

Christopher Klifto, MD

Principal Investigator

Duke University

Oke Anakwenze, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Shoulder Surgery Postoperative Immobilization: An International Survey of Shoulder Surgeons. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The position of sling immobilization influences the outcomes of anatomic total shoulder arthroplasty: a randomized, single-blind, prospective study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Getting Back to Basics: The "Primary" Outcome Measure Determines a Study's Conclusion. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

No difference in complications between two-week vs. six-week duration of sling immobilization after reverse total shoulder arthroplasty. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Abduction Brace Versus Antirotation Sling After Arthroscopic Cuff Repair: The Effects on Pain and Function. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

External rotation immobilization for primary shoulder dislocation: a randomized controlled trial. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A simple shoulder restraint. [2019]