NCT06416618 Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
| NCT ID | NCT06416618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Proximal Humeral Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-05-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are: • Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up? Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale. The study compare operation with either plate or nail fixation to non-surgical treatment. Participants will: * Receive either surgical treatment or non-surgical treatment. * At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L). The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.
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
Contact & Investigator
Line Løjbert Houkjær, M.D.
PRINCIPAL INVESTIGATOR
Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.
Frequently Asked Questions
Who can join the NCT06416618 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 65 Years, studying Proximal Humeral Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06416618 currently recruiting?
Yes, NCT06416618 is actively recruiting participants. Contact the research team at lihol@regionsjaelland.dk for enrollment information.
Where is the NCT06416618 trial being conducted?
This trial is being conducted at Køge, Denmark, Tampere, Finland.
Who is sponsoring the NCT06416618 clinical trial?
NCT06416618 is sponsored by Zealand University Hospital. The principal investigator is Line Løjbert Houkjær, M.D. at Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.. The trial plans to enroll 60 participants.