Osteo Arthritis Shoulders, Rotator Cuff Tears
Conditions
Keywords
Shoulder, Sling
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.
Interventions
DEVICENovel 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.
DEVICETraditional 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.
Sponsors
Orthopedic Institute, Sioux Falls, SD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled model
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient choice of type of sling to utilize from postoperative days 29-42 | 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 | Prior to 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
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Score | Prior to surgery | A validated joint specific patient-determined outcome score (low 0 - 100 high) |
| Single Assessment Numeric Evaluation | Prior to surgery | A validated general patient-determined outcome score (low 0 - 100 high) |
| Shoulder Activity Level | Prior to surgery | A validated shoulder-specific activity score (low 0 - 20 high) |
Countries
United States
Contacts
Primary ContactKeith M Baumgarten, MD
Backup ContactKhris Loe
Outcome results
None listed