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

NCT06869343 | Recruiting

• 2 other identifiers: HSR301914FOT Grant ID 9024-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Early Onset Physical Therapy

ACTIVE COMPARATOR

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

Other: Physical Therapy

Delayed Onset Physical Therapy

ACTIVE COMPARATOR

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

Other: Physical Therapy

Interventions

Physical Therapy OTHER

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

Delayed Onset Physical Therapy; Early Onset Physical Therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• Foundation of Orthopedic Trauma: collaborator

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Humeral Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Seth Yarboro, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Elder

CONTACT

434-924-8570; LJE5U@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 11, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-03

Locations

US (1)