NCT05274737

Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery

Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Orthopedic Institute, Sioux Falls, SD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if the novel shoulder sling has higher patient satisfaction compared to a traditional, abduction sling with at least equivalent postoperative outcomes after arthroscopic rotator cuff repair and total shoulder arthroplasty.

Detailed description

Specific Aim I: To determine if patients undergoing arthroscopic rotator cuff repair prefer the traditional abduction sling vs the novel sling. Specific Aim II: To determine if patients undergoing total shoulder arthroplasty prefer the traditional abduction sling vs the novel sling. Specific Aim III: To determine if short term follow-up (2, 4, 6 weeks), subjective patient-reported outcomes are superior in patients utilizing the novel sling compared to patients utilizing the traditional, abduction sling. Specific Aim IV: To determine if longer term follow-up (6 weeks, 14 weeks, 6 months, and 12 months), validated patient-reported outcomes are similar (non-inferior) in patients utilizing the novel sling compared to a historical control cohort of patients that only utilized the traditional, abduction sling. The purpose of this aim is to ensure that patients that utilize the novel novel sling for 2 to 4 weeks (with the traditional sling used for the rest of the 6 week period) do not have inferior outcomes compared to patients that have worn the traditional sling for a total of 6 weeks.

Conditions

• Rotator Cuff Tears
• Osteo Arthritis Shoulders

Interventions

Type	Name	Description
DEVICE	Novel sling	The novel sling was designed and created by the principal investigator to address these concerns of the traditional slings that are currently available for postsurgical protection and immobilization after shoulder surgery. It is anticipated that the novel sling will allow the patient to be more active and more comfortable while still providing a safe healing environment after a shoulder injury or shoulder surgery.
DEVICE	Traditional abduction sling	An abduction sling is the most common type of sling utilized to protect patients after rotator cuff surgery and total shoulder of arthroplasty and can be considered the current standard of care.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2022-03-10
• Last updated: 2022-06-16

Locations

1 site across 1 country: United States