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

Rotator Cuff Tears Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05274737
Study type Interventional
Source Orthopedic Institute, Sioux Falls, SD
Contact Keith M Baumgarten, MD
Phone 605 339 6828
Email kbaumgarten@ortho-i.com
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date September 2024
View Details
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