Randomized Trial Comparing 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
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.
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.
Inclusion Criteria:
Exclusion Criteria:
kbaumgarten@ortho-i.com605 339 6828
605 339 6828