Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture

A Randomized Controlled Trial of Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture

Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder; Shoulder Arthroplasty; Humerus Fracture; Reverse Shoulder Replacement
• Intervention / Treatment: Other: Physical Therapy

Detailed Description

The overarching goal is to better understand the impact of timing of initiation of rehabilitation on functional and patient reported outcomes on patients undergoing rTSA in the trauma setting.

Specifically, the investigators will conduct a pilot study in the form of a randomized controlled trial to evaluate whether, in patients undergoing rTSA for proximal humerus fracture, early rehabilitation yields a significant difference in range of motion, patient-reported outcomes, or postoperative complications compared to those who undergo delayed rehabilitation. The specific aims are:

Aim 1: To compare the range of motion and patient reported outcomes between early and delayed rehabilitation in patients undergoing rTSA for proximal humerus fracture by conducting a randomized trial. The investigators will enroll patients in a randomized controlled trial postoperatively that will allocate patients to begin physical rehabilitation early (two weeks after operation) or delayed (six weeks after operation). In-person clinic visits and radiographs will occur at multiple time points (six weeks, three months, and six months) postoperatively. The investigators hypothesize that patients undergoing rTSA for proximal humerus fracture participating in early rehabilitation will have no difference in range of motion (forward flexion, abduction) or patient reported outcomes American Shoulder Elbow Surgeons Shoulder Score Constant score.

Aim 2: To compare the rates of postoperative complications between early and delayed rehabilitation in patients undergoing rTSA for proximal humerus fracture. Investigators will conduct chart reviews as well as in-person clinic visits and radiographs at multiple time points postoperatively. Investigators hypothesize that there will be no difference in rates of postoperative complications between early and delayed rehabilitation groups.

The expected outcome of this study is an enhanced understanding of the impact of rehabilitation after proximal humerus fracture, and the degree to which timing of initiation of therapy impacts patient outcomes. This will have a positive impact because it creates a foundation for developing rehabilitation protocols in this population.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Elder; Phone Number: 434-924-8570; Email: LJE5U@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Medical Center
      • Contact: Lori Elder; Phone Number: 434-924-8570; Email: LJE5U@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 50-85 undergo reverse Total Shoulder Arthroplasty by a single surgeon for proximal humerus fractures

Exclusion Criteria:

• previous rTSA to ipsilateral shoulder
• undergoing elective rTSA
• Prisoners
• unwilling to be randomized
• unwilling or unable to attend follow up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early Onset Physical Therapy; Patients in this arm will begin post operative physical therapy at 2 weeks after procedure.	Other: Physical Therapy; Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.
Active Comparator: Delayed Onset Physical Therapy; Patients in this arm will begin post operative physical therapy at 6 weeks after procedure.	Other: Physical Therapy; Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Range of motion of shoulder Forward Flexion using a goniometer	A goniometer will be used to measure forward flexion of the shoulder.	2 week, 6 week, 3 month, and 6 month

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Foundation of Orthopedic Trauma
• Investigators: Principal Investigator: Seth Yarboro, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Musculoskeletal Diseases; Humeral Fractures
• Other Study ID Numbers: HSR301914; FOT Grant ID 9024-2 (Other Grant/Funding Number: Foundation for Orthopaedic Trauma)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No