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

NCT ID: NCT06869343

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-10-31

Brief Summary

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.

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.

Conditions

Orthopedic Disorder; Humerus Fracture; Shoulder Arthroplasty; Reverse Shoulder Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Onset Physical Therapy

Patients in this arm will begin post operative physical therapy at 2 weeks after procedure.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.

Delayed Onset Physical Therapy

Patients in this arm will begin post operative physical therapy at 6 weeks after procedure.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.

Interventions

Physical Therapy

Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation of Orthopedic Trauma

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Seth Yarboro, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth Yarboro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lori Elder

Role: CONTACT

LJE5U@uvahealth.org

434-924-8570

Facility Contacts

Lori Elder

Role: primary

LJE5U@uvahealth.org

434-924-8570

Other Identifiers

FOT Grant ID 9024-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSR301914

Identifier Type: -

Identifier Source: org_study_id