Comparison Of 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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears; Osteo Arthritis Shoulders
• Intervention / Treatment: Device: Novel sling; Device: Traditional abduction sling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keith M Baumgarten, MD; Phone Number: 605 339 6828; Email: kbaumgarten@ortho-i.com
• Study Contact Backup: Name: Khris Loe; Phone Number: 605 339 6828

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Recruiting
      • Orthopedic Institute
      • Contact: Keith M Baumgarten, MD; Phone Number: 605-331-5890

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Immobilization with the novel sling; 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; 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.
Experimental: Initial Postoperative Immobilization with the standard abduction sling; 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; 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.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Orthopedic Institute, Sioux Falls, SD

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Shoulder; Sling
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Osteoarthritis; Rotator Cuff Injuries
• Other Study ID Numbers: Sling study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently there is not a plan to allow IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No