Recruiting

Novel Sling vs. Traditional SlingComparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery

Sponsor:

Orthopedic Institute, Sioux Falls, SD

Code:

NCT05274737

Conditions

Rotator Cuff Tears

Osteo Arthritis Shoulders

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Novel sling

Traditional abduction sling

Study Details

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

Study ID

NCT05274737

Start date

Mar 1, 2022

Status verified date

Jun, 2022

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Primary outcome measure

Patient choice of type of sling to utilize from postoperative days 29-42 [ Time Frame: 6 weeks after surgery ]
Sling satisfaction survey [ Time Frame: Prior to surgery ]
Sling satisfaction survey [ Time Frame: 14 days after surgery ]
Sling satisfaction survey [ Time Frame: 15 days after surgery ]
Sling satisfaction survey [ Time Frame: 28 days after surgery ]
Sling satisfaction survey [ Time Frame: 6 weeks after surgery ]
Sling satisfaction survey [ Time Frame: 14 weeks after surgery ]
Sling satisfaction survey [ Time Frame: 6 months after surgery ]
Sling satisfaction survey [ Time Frame: 12 months after surgery ]

Central Contacts and Locations

Central contacts

Keith M Baumgarten, MD

605 339 6828 kbaumgarten@ortho-i.com

Khris Loe

605 339 6828

Locations

Orthopedic Institute

Recruiting

Sioux Falls, South Dakota, United States, 57117

Contacts

Keith M Baumgarten, MD

605-331-5890

More Information

Sponsor

Orthopedic Institute, Sioux Falls, SD

Last update posted

Jun 16, 2022

Last verified

Jun, 2022

Keywords

Shoulder
Sling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orthopedic Institute, Sioux Falls, SD on 2022-06-16.