None listed
Conditions
Brief summary
Proximal humeral fractures (PHFs) are among the most common osteoporotic fractures in older adults and represent an increasing healthcare burden. The incidence of PHFs rises with age, with a substantial proportion of displaced fractures requiring surgical management. The PHINZ trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost-effectiveness of intramedullary nails (IMN) compared with locking plates (LP) fixation for patients with three-part proximal humeral fractures. Adults aged 18 years or older with radiographically confirmed three-part fractures will be screened for eligibility across five New Zealand centres. Participants will be randomised 1:1 to receive either IMN or LP fixation, with standardised surgical techniques and post-operative rehabilitation protocols. Stratification by age group and treating centre will be used to ensure balanced allocation between treatment groups. The primary outcome is the Oxford Shoulder Score at 12 months post-operatively. Secondary outcomes include pain, upper limb function, shoulder-specific outcome measures, range of motion, muscle strength, health-related quality of life, complications, and healthcare costs. Participants will be followed for 12 months to evaluate clinical outcomes and cost-effectiveness. This trial will provide high-quality evidence comparing two commonly used surgical techniques for three-part PHFs and will help inform clinical decision-making regarding the optimal surgical approach for improving patient outcomes and healthcare value.
Interventions
Intramedullary Nail (IMN) group:
Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will operate on patients under general anesthesia in the beach chair position with the elbow fixed at 90°. Skin will be opened via deltopectoral or deltoid split approach at surgeon's preference. Also, patients may have separate incisions as required. The greater and lesser tuberosities are re-approximated and sutured using non-absorbable suture. Once bony fragments a
Intramedullary Nail (IMN) group: Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will operate on patients under general anesthesia in the beach chair position with the elbow fixed at 90°. Skin will be opened via deltopectoral or deltoid split approach at surgeon's preference. Also, patients may have separate incisions as required. The greater and lesser tuberosities are re-approximated and sutured using non-absorbable suture. Once bony fragments are reduced, K-wires/sutures will be used under image intensifier guidance (fluoroscopy) to temporarily fix the head before implant use. Implant will be Tornier AEQUALIS Intramedullary Humeral Nail, a straight nail, 130 mm length and 8 mm distal diameter. This nail has 4 cannulated proximal screws to provide fixation perpendicular to fracture lines and to avoid reduction loss due to the pull-out force of rotator cuff. Two distal screws are designed to control rotation. The medullary canal is opened using cannulated drill and nail will then be inserted once the reduction is stable. The intraoperative duration for this procedure was reported between 50 to 85 minutes. Adherence to the intervention will be confirmed via checking randomization result in REDCap (Research Electronic Data Capture) where patients and treating members are aware of group allocation) and shoulder radiography during operation.
Sponsors
University of Otago-Christchurch
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients above 18 years old with displaced three-part proximal humerus fractures based on the Neer classification will be included. In three-part fractures, either the lesser or greater tuberosity is displaced with associated displacement of the surgical neck producing a rotational deformity. Displaced fractures will be defined as a dislocation more than 1 cm or with an angle greater than 45° between head and diaphysis of humerus. The type of fractures will be classified according to the Neer-classification.
Exclusion criteria
Exclusion criteria will be fractures extending to the humeral shaft or articular split, fractures more than 4 weeks old, or open fractures. Patients will be excluded if they are identified with concomitant ipsilateral fractures of distal humerus/or elbow joint, previous surgery of affected shoulder, pathologic fracture (i.e., malignancy fractures), neurovascular injuries (e.g., stroke or brachial plexus injuries), neurological disorders (e.g., Parkinson, or multiple sclerosis), or cognitive disorders (i.e., sever mental illness). Intra operative changes of treatment due to small diameter of humerus shaft, fracture line through the nail entry point or severely reduced bone quality resulting in fixation problems with either implants will be excluded.
Outcome results
None listed