Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears
- Sponsor
- Orthopedic Institute, Sioux Falls, SD
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Patient choice of type of sling to utilize from postoperative days 29-42
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Keith Baumgarten
Principal Investigator
Orthopedic Institute, Sioux Falls, SD
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
- •Dominant extremity undergoing surgery
Exclusion Criteria
- •Patients undergoing revision surgery
- •Patients with a history of significant cervical spine disease, peripheral neuropathy, or concomitant wrist or elbow disorders
- •Patients that do not understand English
- •Patients unwilling to participate or follow up for the study protocols
Outcomes
Primary Outcomes
Patient choice of type of sling to utilize from postoperative days 29-42
Time Frame: 6 weeks after surgery
Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period
Sling satisfaction survey
Time Frame: 12 months after surgery
a novel, sling satisfaction score (SSS) \[scale 0= best to 10=worst\] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use
Secondary Outcomes
- American Shoulder and Elbow Surgeons Score(12 months after surgery)
- Shoulder Activity Level(12 months after surgery)
- Single Assessment Numeric Evaluation(12 months after surgery)