Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Launched by ZEALAND UNIVERSITY HOSPITAL · May 14, 2024
Trial Information
Current as of February 18, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different ways to treat a specific type of shoulder fracture called a displaced proximal humerus fracture in adults aged 50 to 65. The main goal is to find out if surgery, which involves fixing the bone with plates or nails, leads to better recovery and function compared to non-surgical treatment, which might include physical therapy and rest. Participants will answer short questionnaires about their shoulder function and quality of life at 6 months, 1 year, and 2 years after their treatment to help researchers understand which approach is more effective.
To be eligible for this trial, participants need to be between 50 and 65 years old and have a specific type of shoulder fracture that can be treated effectively. They should also be able to understand and respond to follow-up questions. If someone decides to join the study, they will either receive the surgical treatment or the non-surgical treatment, and their progress will be monitored closely over time. It’s important to know that this study is currently recruiting participants, and those with certain types of fractures or other health issues may not qualify.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility.
- • Patients should be cognitively capable of answering the follow-up questionnaires.
- Exclusion Criteria:
- • The patient does not understand written and spoken native language (Danish or Finnish/Swedish)
- • Inability to give informed consent
- • Fractures assessed to be unreconstructedly by the treating surgeon
- • Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface
- • Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks.
- • Pathological fractures or previous fractures in the same proximal humerus
- • Concomitant fractures, which could influence the outcome
- • Paralysis in upper extremity
Trial Officials
Line Løjbert Houkjær, M.D.
Principal Investigator
Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.
About Zealand University Hospital
Zealand University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive expertise in various medical fields to improve patient outcomes and enhance treatment methodologies. With a commitment to rigorous scientific standards and ethical practices, Zealand University Hospital collaborates with multidisciplinary teams to explore new therapies and interventions, contributing significantly to the global body of medical knowledge. Through its state-of-the-art facilities and focus on patient-centered care, the hospital plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampere, , Finland
Køge, Region Zealand, Denmark
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0