None listed
Conditions
Brief summary
Our objective is to conduct a preliminary randomized controlled trial (RCT) to build the capacity for a large-scale RCT. We will compare Intramedullary Nail (IMN) and Locking Plate (LP) fixation for three-part Proximal Humerus Fractures (PHFs). The pilot trial involves 12 patients aged above 18 with displaced three-part PHFs, randomly assigned to IMN or LP groups. Standard surgical procedures and post-operative rehabilitation will be provided. We will assess pain using the Visual Analogue Scale and functional outcome using 'Disability of the Arm, Shoulder, and Hand' (DASH), 'Constant Murley,' and 'American Shoulder and Elbow Surgeons' (ASES) assessments at 3- and 6-months post-surgery. Complications will be monitored during clinical visits. This study will establish a research team and test RCT aspects before a multi-center RCT.
Interventions
Intramedullary Nail (IMN) group:
The study will be performed at Christchurch Hospital. Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will contribute to operation. Patients will be operated 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 tuberositi
Intramedullary Nail (IMN) group: The study will be performed at Christchurch Hospital. Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will contribute to operation. Patients will be operated 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
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with displaced three-part proximal humerus fractures based on 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.
Exclusion criteria
1) Fractures extending to the humeral shaft 2) Articular split, 3) fractures more than 4 weeks old, 4) open fractures. 5) Concomitant ipsilateral fractures of distal humerus/ or elbow joint, 6) Previous surgery of affected shoulder, 7) Pathologic fracture (malignancy fractures), 8) Neurovascular injuries (e.g., stroke, or brachial plexus injuries), 9) Neurological disorders (e.g., Parkinson, or multiple sclerosis) or cognitive disorders (i.e., sever mental illness). 10) Intra operative changes of treatment due to small diameter of humerus shaft to use nail, fracture line through the nail entry point or severely reduced bone quality resulting in fixation problems with either implants.
Outcome results
None listed