Recruiting

rTSA

Sponsor:

University of Virginia

Code:

NCT06869343

Conditions

Orthopedic Disorder

Humerus Fracture

Shoulder Arthroplasty

Reverse Shoulder Replacement

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Physical Therapy

Study Details

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

Study ID

NCT06869343

Start date

May 19, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Early Onset Physical Therapy

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

active comparator: Delayed Onset Physical Therapy

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

Interventions

Physical Therapy

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

Primary outcome measure

  • Measurement of Range of motion of shoulder Forward Flexion using a goniometer [ Time Frame: 2 week, 6 week, 3 month, and 6 month ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-09.