Interventions for treating proximal humeral fractures in adults.
Helen Hg Handoll, Joanne Elliott, Theis M Thillemann...
https://pubmed.ncbi.nlm.nih.gov/35727196Actively Recruiting
Phase Not Applicable
Age: 50Years - 65Years
All Genders
ID06416618
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial
Led by Zealand University Hospital · Updated on 2025-09-18
60
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to determine whether surgery leads to better functional outcomes than non-surgical treatment in patients aged 50 to 65 with displaced proximal humerus fractures. The study focuses on comparing osteosynthesis using either plate or intramedullary nail fixation to non-surgical care, while also examining factors like fracture type, osteoporosis status, and clinical frailty in this age group. Current knowledge mainly comes from older populations, so this trial fills an important gap for younger adults. Participants will be randomly assigned to receive either surgical treatment with osteosynthesis or non-surgical management. The surgical group will have follow-up visits at 2, 12, and 24 weeks with clinical and radiological assessments, while the non-surgical group will have visits at 6, 12, and 24 weeks. Both groups are referred to rehabilitation services. Surgical patients use a sling post-operation, while non-surgical patients may be offered an optional sling for comfort. During the study, participants will complete questionnaires including the Oxford Shoulder Score and EQ-5D-3L at 6 months, 12 months, and 24 months to assess function and quality of life. Researchers will monitor adverse events, any need for additional surgery, and rehabilitation adherence. The primary outcome is the Oxford Shoulder Score at 12 months, with additional evaluations at 6 and 24 months. Safety and treatment failures will also be tracked throughout the two-year follow-up.
CONDITIONS
Brief Title
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Who Can Participate
Age: 50Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged between 50 and 65 years with a displaced proximal humerus fracture deemed reconstructible by the treating surgeon
- Patients able to understand and communicate in Danish, Finnish, or Swedish
- Patients cognitively capable of answering follow-up questionnaires
- Patients able to give informed consent
You will not qualify if you...
- Patients unable to understand written and spoken Danish, Finnish, or Swedish
- Inability to give informed consent
- Fractures assessed as unreconstructible by the treating surgeon
- Isolated tuberosity fractures, fracture dislocations, open fractures, or fractures involving the joint surface
- Less than 25% contact between head fragment and metaphysis/diaphysis on X-rays at two weeks
- Pathological fractures or previous fractures in the same proximal humerus
- Concomitant fractures that may affect outcome
- Paralysis in the upper extremity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Immediate post-surgery period
Participants assigned to the surgical group will undergo osteosynthesis and receive a sling and swathe immediately after surgery. From the first postoperative day, only the sling is used.
No specific visits during immediate post-operative care
Treatment
Duration - Up to 24 weeks post-injury
Participants receive either surgical treatment with osteosynthesis or non-surgical treatment with optional sling use for comfort. Both groups are referred to rehabilitation in the municipalities.
Surgical group: 3 outpatient visits at 2, 12, and 24 weeks post-surgery; Non-surgical group: 3 visits at 2 weeks (10-14 days), 6 weeks, and 24 weeks post-injury
Follow-up
Duration - Up to 24 months
Participants are monitored with clinical and radiological assessments, including x-rays before every visit. Outcome measures such as shoulder function and quality of life are collected at 6, 12, and 24 months.
Visits at 6, 12, and 24 months for outcome assessments
Trial Site Locations
Total: 2 locations
1
Centre for Evidence-Based Orthopaedics, Zealand University Hospital
Køge, Region Sjælland, Denmark, 4600
Actively Recruiting
2
Tampere University Hospital
Tampere, Finland, 33520
Not Yet Recruiting
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Research Team
L
Line Løjbert Houkjær, M.D., ph.d.-student
S
Stig Brorson, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions.
N Alispahic, S Brorson, C Bahrs...
https://pubmed.ncbi.nlm.nih.gov/32456631Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions.
Stig Brorson, Nikola Alispahic, Christian Bahrs...
https://pubmed.ncbi.nlm.nih.gov/30797232Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process.
Laurent Audigé, Stig Brorson, Holger Durchholz...
https://pubmed.ncbi.nlm.nih.gov/34847888Surgical versus non‑surgical treatment of proximal humerus fracture in patients aged 50-65 years: young shoulder CARE (displaCed proximAl humeRus fracturE) trial-a pragmatic randomized controlled trial study protocol.
Line Houkjær, Antti P Launonen, Bakir O Sumrein...
https://pubmed.ncbi.nlm.nih.gov/41466383