RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures

Mayo Clinic

Status: Terminated

Conditions: Humerus Fracture; Shoulder Arthropathy Associated With Other Conditions; Shoulder Fractures; Arthropathy Shoulder; Shoulder Injury; Humerus; Arthropathy

Treatments: Other: Nonoperative Treatment; Procedure: Reverse Total Shoulder Arthroplasty (rTSA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03599336

18-002097

Details and patient eligibility

About

There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.

Enrollment: 4 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Displaced 3- and 4-part proximal humerus fractures.
• Age greater than or equal to 65 years old.

Exclusion Criteria

• Less than 65 years old.
• Medical comorbidities precluding surgical treatment or anesthesia
• Dementia or inability to provide adequate follow up.
• Pathologic fractures
• Open fractures
• Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Nonoperative Treatment

Other group

Description:

Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.

Treatment:

Other: Nonoperative Treatment

Operative Course for rTSA

Other group

Description:

Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.

Treatment:

Procedure: Reverse Total Shoulder Arthroplasty (rTSA)