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

Orthopedic Institute, Sioux Falls, SD

Status: Enrolling

Conditions: Osteo Arthritis Shoulders; Rotator Cuff Tears

Treatments: Device: Novel sling; Device: Traditional abduction sling

Study type: Interventional

Funder types: Other

Identifiers

NCT05274737

Sling study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Initial Immobilization with the novel sling

Experimental group

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.

Treatment:

Device: Novel sling

Initial Postoperative Immobilization with the standard abduction sling

Experimental group

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.

Treatment:

Device: Traditional abduction sling