University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Location status: Recruiting
NCT Number: NCT06869343
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.
Interested in participating?
Request Info50 year–85 year
All sexes
Interventional
Not applicable
Charlottesville, Virginia, 22908, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.
Time frame: 2 week, 6 week, 3 month, and 6 month
A goniometer will be used to measure forward flexion of the shoulder.
Contact information is provided by the study sponsor or research team.
University of Virginia
Other
A Randomized Controlled Trial of Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05461326
Anterior Cruciate Ligament Injuries, Knee Injuries
Birmingham, Alabama, United States
View Trial DetailsNCT05381818
Arthropathy of Hip, Arthropathy of Knee
Jacksonville, Florida, United States
View Trial DetailsNCT06991205
Chronic Pain, Musculoskeletal Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT06459986
Musculoskeletal Diseases, Orthopedic Disorder
Hillerød, Denmark
View Trial Details