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

NCT ID: NCT05274737

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-09-30

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.

Conditions

Rotator Cuff Tears; Osteo Arthritis Shoulders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Novel sling

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Traditional abduction sling

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopedic Institute, Sioux Falls, SD

OTHER

Sponsor Role: lead

Responsible Party

Keith Baumgarten

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orthopedic Institute

Sioux Falls, South Dakota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Keith M Baumgarten, MD

Role: CONTACT

kbaumgarten@ortho-i.com

605 339 6828

Khris Loe

Role: CONTACT

605 339 6828

Facility Contacts

Keith M Baumgarten, MD

Role: primary

605-331-5890

Other Identifiers

Sling study

Identifier Type: -

Identifier Source: org_study_id