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

NCT05274737 | Unknown

• 1 other identifier: Sling study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Osteo Arthritis Shoulders

Keywords

Shoulder; Sling

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (13)

• American Shoulder and Elbow Surgeons Score

  Prior to surgery

• American Shoulder and Elbow Surgeons Score

  14 weeks after surgery

• American Shoulder and Elbow Surgeons Score

  6 months after surgery

• American Shoulder and Elbow Surgeons Score

  12 months after surgery

• Single Assessment Numeric Evaluation

  Prior to surgery

Study Arms (2)

Initial Immobilization with the novel sling

EXPERIMENTAL

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

Initial Postoperative Immobilization with the standard abduction sling

EXPERIMENTAL

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

Interventions

Novel sling DEVICE

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.

Initial Immobilization with the novel sling

Traditional abduction sling DEVICE

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.

Initial Postoperative Immobilization with the standard abduction sling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
• Dominant extremity undergoing surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopedic Institute, Sioux Falls, SD: lead

Study Sites (1)

Orthopedic Institute

Sioux Falls, South Dakota, 57117, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Keith M Baumgarten, MD

CONTACT

605 339 6828; kbaumgarten@ortho-i.com

Khris Loe

CONTACT

605 339 6828

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled model

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)