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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rotator Cuff Tears, Osteo Arthritis Shoulders

Intervention / Treatment
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* Device: Novel sling
* Device: Traditional abduction sling


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, controlled model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial Immobilization with the novel sling<br>20 patients will be placed in the novel sling after surgery for the first two weeks. For the second two weeks (days 15-28) they will crossover and utilize the standard abduction sling. For the final two weeks (days 29-42) they will choose their preferred sling type and use it for the remainder of six week immobilization period. | Device: Novel sling<br>* 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.<br>|
| Experimental: Initial Postoperative Immobilization with the standard abduction sling<br>20 patients will be placed in the traditional abduction sling after surgery for the first two weeks. For the second two weeks (days 15-28) they will crossover and utilize the novel sling. For the final two weeks (days 29-42) they will choose their preferred sling type and use it for the remainder of six week immobilization period. | Device: Traditional abduction sling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient choice of type of sling to utilize from postoperative days 29-42 | Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period | 6 weeks after surgery | 
| Sling satisfaction survey | 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 | Prior to surgery | 
| Sling satisfaction survey | 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 and satisfaction with the type of sling utilized during this time period | 14 days after surgery | 
| Sling satisfaction survey | 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 and satisfaction with the type of sling utilized during this time point. The rationale for recording both the day 14 and day 15 SSS is to get the patient's immediate impression on the potential subjective differences between the slings within 24 hours of changing to the alternate sling. | 15 days after surgery | 
| Sling satisfaction survey | 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 and satisfaction with the type of sling utilized during this time period | 28 days after surgery | 
| Sling satisfaction survey | 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 and satisfaction with the type of sling utilized during this time period | 6 weeks after surgery | 
| Sling satisfaction survey | 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 | 14 weeks after surgery | 
| Sling satisfaction survey | 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 | 6 months after surgery | 
| Sling satisfaction survey | 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 | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | Prior to surgery | 
| American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 14 weeks after surgery | 
| American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 6 months after surgery | 
| American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 12 months after surgery | 
| Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | Prior to surgery | 
| Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 6 weeks after surgery | 
| Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 14 weeks after surgery | 
| Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 6 months after surgery | 
| Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 12 months after surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | Prior to surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 14 weeks after surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 6 months after surgery | 
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sling, Shoulder