Sling vs No Sling After Reverse Total Shoulder Arthroplasty

N/AActive Not RecruitingNCT06092996

Duke University100 enrolled

Overview

This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study. Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively. Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure * Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy * Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis * Rotator cuff arthropathy * Glenohumeral arthritis * Patient is between 18-100 years old * Patient is English speaking Exclusion Criteria: * A history of ipsilateral shoulder arthroplasty * A history of shoulder septic arthritis * A history of a proximal humeral fracture * Chronic locked dislocation * Rheumatoid arthritis * Tumors * Axillary nerve damage * Non-functioning deltoid muscle * Glenoid vault deficiency precluding baseplate fixation * Infection and neuropathic joints * Known or suspected non-compliance, drug or alcohol abuse * Patients incapable of judgement or under tutelage * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. * The subject is related to investigator as family members, employees, or other dependent persons

Outcomes

Primary Outcomes

Number of participants who develop any kind of postoperative complication

Incidence of postoperative complications

Time frame: 6 months primary, Up to the first 2 years following surgery

Secondary Outcomes

American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score

The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

Time frame: 6 months primary, Up to the first 2 years following surgery

Single Assessment Numeric Evaluation (SANE) score

The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function.

Time frame: 6 months primary, Up to the first 2 years following surgery

Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes