100 Participants Needed

Sling Use After Shoulder Surgery

CQ
Overseen ByCaroline Questell, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12467

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.12367

Research Team

CK

Christopher Klifto, MD

Principal Investigator

Duke University

OA

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.
See 5 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: No SlingExperimental Treatment1 Intervention
Participants in the no sling group will only wear a sling for three days postoperatively
Group II: SlingActive Control1 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)

Find a Clinic Near You

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

References

Shoulder Surgery Postoperative Immobilization: An International Survey of Shoulder Surgeons. [2023]
The position of sling immobilization influences the outcomes of anatomic total shoulder arthroplasty: a randomized, single-blind, prospective study. [2019]
Getting Back to Basics: The "Primary" Outcome Measure Determines a Study's Conclusion. [2019]
No difference in complications between two-week vs. six-week duration of sling immobilization after reverse total shoulder arthroplasty. [2023]
Abduction Brace Versus Antirotation Sling After Arthroscopic Cuff Repair: The Effects on Pain and Function. [2018]
External rotation immobilization for primary shoulder dislocation: a randomized controlled trial. [2022]
A simple shoulder restraint. [2019]
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