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

Last updated: June 13, 2022
Sponsor: Orthopedic Institute, Sioux Falls, SD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT05274737
Sling study
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 40
Study Start date:
March 01, 2022
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Orthopedic Institute

    Sioux Falls, South Dakota 57117
    United States

    Active - Recruiting

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