Surgery vs Non-Surgery for Proximal Humerus Fractures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares surgical and non-surgical options for treating shoulder fractures near the top of the arm (proximal humerus fractures). The goal is to determine which approach aids recovery more effectively after the injury. Participants will either undergo surgery, which may involve procedures such as intramedullary nail (a type of internal fixation), open reduction internal fixation (a surgical method to fix broken bones), or reverse total shoulder arthroplasty (a type of shoulder replacement), or manage their condition without surgery. The trial seeks individuals aged 65 or older who have experienced this type of fracture. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments studied for shoulder fractures near the top of the arm bone have varying safety levels.
For intramedullary nails, studies report a complication rate of about 18.9%, with a 6.8% chance of requiring additional surgery. However, many patients experience good shoulder function after this treatment.
Open reduction internal fixation (ORIF) can yield excellent results when performed correctly, but it may have higher complication rates and necessitate more follow-up surgeries compared to other methods.
Reverse total shoulder arthroplasty (RTSA) has a lower complication rate of around 9.1% and reduces the likelihood of additional surgery by 63% compared to ORIF. It also tends to provide good long-term outcomes.
These findings suggest that while risks exist, each treatment is generally well-tolerated according to various studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for proximal humerus fractures because they offer different approaches to shoulder repair. The intramedullary nail is less invasive and can promote faster recovery compared to traditional plates and screws. Open reduction internal fixation allows for precise alignment of bone fragments, potentially improving joint function and reducing long-term complications. Lastly, reverse total shoulder arthroplasty is particularly beneficial for older patients with severe fractures, as it can restore shoulder function even when rotator cuff muscles are compromised. Each of these options provides distinct advantages over standard non-surgical management, offering hope for improved outcomes in diverse patient populations.
What evidence suggests that this trial's treatments could be effective for proximal humerus fractures?
This trial will compare surgical and non-surgical approaches for treating upper arm bone fractures near the shoulder. Research has shown that various surgical methods, such as intramedullary nailing (IMN), open reduction internal fixation (ORIF), and reverse total shoulder arthroplasty, lead to good recovery. Participants in the operative management arm of this trial may receive one of these surgical treatments. Intramedullary nailing often restores good movement and function, especially for simpler fractures. Open reduction and internal fixation are commonly used and effective, but the choice of treatment usually depends on the fracture's complexity. Reverse total shoulder arthroplasty is another option sometimes used for more severe cases. Overall, these surgeries have improved shoulder function and movement for many patients with these types of fractures.16789
Who Is on the Research Team?
Wayne Chan, MD
Principal Investigator
UMass Chan Medical School
Are You a Good Fit for This Trial?
This trial is for individuals with proximal humerus fractures, which are breaks near the top of the upper arm bone close to the shoulder. Details on who can join or reasons for exclusion aren't provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either operative or non-operative management of proximal humerus fractures
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- intramedullary nail
- open reduction internal fixation
- reverse total shoulder arthroplasty
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor