Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years

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.

Conditions

• Proximal Humeral Fracture
• Shoulder Fractures

Interventions

PROCEDURE

Surgical

Surgical group: After osteosynthesis, they will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. They will be referred to post-operative rehabilitation in the municipalities. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail.

PROCEDURE

Non surgical

Non-surgical group: Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit, 10-14 days post-injury. Patients will be referred to rehabilitation in the municipalities. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments.

Sponsors & Collaborators

• Tampere University Hospital

  collaborator OTHER

• Zealand University Hospital

  lead OTHER

Principal Investigators

• Line Løjbert Houkjær, M.D. · Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-15

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• Denmark
• Finland

Study Locations