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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tears; Osteo Arthritis Shoulders
• Interventions: Device: Traditional abduction sling; Device: Novel sling

• Registration Number: NCT05274737
• Lead Sponsor: Orthopedic Institute, Sioux Falls, SD

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study Start: 2022-03-01
• Study First Posted: 2022-03-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16
• Primary Completion: 2023-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Initial Postoperative Immobilization with the standard abduction sling	Traditional 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.
Initial Immobilization with the novel sling	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.

Primary Outcome Measures

Name	Time	Method
Patient choice of type of sling to utilize from postoperative days 29-42	6 weeks after surgery	Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period
Sling satisfaction survey	12 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons Score	12 months after surgery	A validated joint specific patient-determined outcome score (low 0 - 100 high)
Shoulder Activity Level	12 months after surgery	A validated shoulder-specific activity score (low 0 - 20 high)
Single Assessment Numeric Evaluation	12 months after surgery	A validated general patient-determined outcome score (low 0 - 100 high)

Trial Locations

Locations (1)

Orthopedic Institute; 🇺🇸 Sioux Falls, South Dakota, United States