Clinical trial NCT05274737: Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
Official title: Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Osteo Arthritis Shoulders
Keywords: Shoulder
Sling
Lead sponsor: Orthopedic Institute, Sioux Falls, SD
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled model
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient choice of type of sling to utilize from postoperative days 29-42
timeFrame: 6 weeks after surgery
measure: Sling satisfaction survey
timeFrame: Prior to surgery
measure: Sling satisfaction survey
timeFrame: 14 days after surgery
measure: Sling satisfaction survey
timeFrame: 15 days after surgery
measure: Sling satisfaction survey
timeFrame: 28 days after surgery
measure: Sling satisfaction survey
timeFrame: 6 weeks after surgery
measure: Sling satisfaction survey
timeFrame: 14 weeks after surgery
measure: Sling satisfaction survey
timeFrame: 6 months after surgery
measure: Sling satisfaction survey
timeFrame: 12 months after surgery
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Score
timeFrame: Prior to surgery
measure: American Shoulder and Elbow Surgeons Score
timeFrame: 14 weeks after surgery
measure: American Shoulder and Elbow Surgeons Score
timeFrame: 6 months after surgery
measure: American Shoulder and Elbow Surgeons Score
timeFrame: 12 months after surgery
measure: Single Assessment Numeric Evaluation
timeFrame: Prior to surgery
measure: Single Assessment Numeric Evaluation
timeFrame: 6 weeks after surgery
measure: Single Assessment Numeric Evaluation
timeFrame: 14 weeks after surgery
measure: Single Assessment Numeric Evaluation
timeFrame: 6 months after surgery
measure: Single Assessment Numeric Evaluation
timeFrame: 12 months after surgery
measure: Shoulder Activity Level
timeFrame: Prior to surgery
measure: Shoulder Activity Level
timeFrame: 14 weeks after surgery
measure: Shoulder Activity Level
timeFrame: 6 months after surgery
measure: Shoulder Activity Level
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Orthopedic Institute
state: South Dakota
Study officials:
References: