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

Primary Purpose

Rotator Cuff Tears, Osteo Arthritis Shoulders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel sling
Traditional abduction sling
Sponsored by
Orthopedic Institute, Sioux Falls, SD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Shoulder, Sling

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Initial Immobilization with the novel sling

Initial Postoperative Immobilization with the standard abduction sling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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.
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
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
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
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
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

Secondary Outcome Measures

American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)

Full Information

First Posted
February 28, 2022
Last Updated
June 13, 2022
Sponsor
Orthopedic Institute, Sioux Falls, SD
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1. Study Identification

Unique Protocol Identification Number
NCT05274737
Brief Title
Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
Official Title
Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopedic Institute, Sioux Falls, SD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Osteo Arthritis Shoulders
Keywords
Shoulder, Sling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, controlled model
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Initial Immobilization with the novel sling
Arm Type
Experimental
Arm Description
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.
Arm Title
Initial Postoperative Immobilization with the standard abduction sling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Novel sling
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional abduction sling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient choice of type of sling to utilize from postoperative days 29-42
Description
Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period
Time Frame
6 weeks after surgery
Title
Sling satisfaction survey
Description
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
Time Frame
Prior to surgery
Title
Sling satisfaction survey
Description
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
Time Frame
14 days after surgery
Title
Sling satisfaction survey
Description
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.
Time Frame
15 days after surgery
Title
Sling satisfaction survey
Description
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
Time Frame
28 days after surgery
Title
Sling satisfaction survey
Description
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
Time Frame
6 weeks after surgery
Title
Sling satisfaction survey
Description
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
Time Frame
14 weeks after surgery
Title
Sling satisfaction survey
Description
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
Time Frame
6 months after surgery
Title
Sling satisfaction survey
Description
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
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
Prior to surgery
Title
American Shoulder and Elbow Surgeons Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
14 weeks after surgery
Title
American Shoulder and Elbow Surgeons Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
6 months after surgery
Title
American Shoulder and Elbow Surgeons Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
12 months after surgery
Title
Single Assessment Numeric Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
Prior to surgery
Title
Single Assessment Numeric Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
6 weeks after surgery
Title
Single Assessment Numeric Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
14 weeks after surgery
Title
Single Assessment Numeric Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
6 months after surgery
Title
Single Assessment Numeric Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
12 months after surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
Prior to surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
14 weeks after surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
6 months after surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith M Baumgarten, MD
Phone
605 339 6828
Email
kbaumgarten@ortho-i.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khris Loe
Phone
605 339 6828
Facility Information:
Facility Name
Orthopedic Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith M Baumgarten, MD
Phone
605-331-5890

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is not a plan to allow IPD with other researchers

Learn more about this trial

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

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