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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274737
• Other study ID #: Sling study
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2022
• Source: Orthopedic Institute, Sioux Falls, SD
• Contact: Keith M Baumgarten, MD
• Phone: 605 339 6828
• Email: kbaumgarten[@]ortho-i.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Shoulders
• Osteoarthritis
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Orthopedic Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Orthopedic Institute, Sioux Falls, SD

Country where clinical trial is conducted

United States, 

Outcome

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