Comparing surgical and non-surgical treatments for two-part proximal humerus fractures
Conservative Versus Operative Treatment of Two - Part Proximal Humerus Fractures
This study is testing whether surgery or non-surgical treatment works better for older adults with certain shoulder fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Akershus Academic / other |
| Locations | 1 site (Lørenskog, Oslo) |
| Trial ID | NCT04106674 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of surgical versus conservative management for displaced two-part proximal humerus fractures in patients aged 60 to 85. Participants will be randomly assigned to receive either open reduction and internal fixation (ORIF) or non-operative treatment. The study will assess functional outcomes using the Quick DASH score and other evaluations at multiple follow-up points over a year. The trial is designed as a single-blinded randomized controlled trial conducted at Akershus University Hospital.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 60 to 85 with displaced two-part proximal humeral fractures requiring treatment.
Not a fit: Patients with fractures older than three weeks or those who refuse to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for elderly patients with proximal humerus fractures, potentially improving recovery outcomes.
How similar studies have performed: Other studies have explored surgical versus non-surgical treatments for similar fractures, but this specific comparison in the elderly population is less common, making it a valuable investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
-The study-design is a single center single blinded randomized controlled trial (RCT) with 3 arms. Patients admitted to Akershus University Hospital with a displaced 2-part proximal humeral fracture of OTA/ AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative/ non-operative treatment or open reduction and internal fixation (ORIF). The patients allocated to ORIF will be randomly allocated to either the Philos plate (Synthes) or the Multiloc nail (Synthes). Inclusion criteria 1. Patients \> 60 years and \<85 years 2. More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA). 3. Patient with tuberculum majus or minor fractures which displaced \<5mm can be included as long as points 1 and 2 above are fulfilled. Exclusion Criteria: * Refusal to participate in the study * Fracture more than 3 weeks old * No contact btw head and shaft * Ipsilateral damage that will influence the recovery and scoring systems * Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide * Pathological fracture or previous fracture of the same proximal humerus * Multitrauma or "multifractured patient" * Neurovascular injury * Open fracture * Noncompliance, dementia and/ or institutionalized * Congenital anomaly * Ongoing infectious process around the incision site for osteosynthesis * Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis/Multiple sclerosis/ poorly controlled DM) * Fracture dislocation * Substance abuse * Inability to read and understand Norwegian * Patients not residing in our catchment area * Patients with a diameter of the humerus to small for nailing, will be allocated to the Philos-group. * Any medical condition that excludes surgical treatment, including patients with ASA 3 or 4 that are considered too ill to go through surgery.
Where this trial is running
Lørenskog, Oslo
- Akershus University Hospital — Lørenskog, Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Annette Konstanse Bordewich Wikerøy, MD
- Email: awikeroy@hotmail.com
- Phone: 004799717481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.