Functional and radiological comparison of multilock nail and proximal humerus locking plate in proximal humerus fractures: A randomized study.
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
Study Overview
Brief Summary
Proximal humerus fractures are common injuries in adults and their management remains challenging due to variation in fracture patterns and bone quality. Surgical fixation is often preferred to restore shoulder function and prevent long term disability. Two commonly used fixation methods are the Multilock intramedullary nail and the Proximal Humerus Locking Plate. Previous studies have shown differing results regarding functional recovery, radiological healing, and complication rates between these two implants. The Multilock nail represents the latest generation of intramedullary devices with improved biomechanics and reduced soft tissue damage.
This prospective randomized comparative study aims to evaluate and compare the functional and radiological outcomes of Multilock nail fixation versus Proximal Humerus Locking Plate fixation in patients with proximal humerus fractures. A total of sixty four patients will be included and randomized into two groups. Functional outcome will be assessed using Visual Analog Score, ASES score, and QuickDASH score. Radiological outcomes will include time to union and changes in neck shaft angle. Complications such as infection, implant failure, malunion, and shoulder stiffness will also be recorded.
The study will help determine which surgical method provides better clinical outcomes and may guide surgeons in selecting the appropriate fixation method for proximal humerus fractures.
I
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 years.
- •65 YRS 2)NEER 2, 3, 4 part Proximal Humerus Fracture 3)Normal pre-injury shoulder function.
Exclusion Criteria
- •Head split fractures, fracture dislocation 2)Neurovascular injury(Brachial plexus injury -flail arm) 3)Chronic shoulder pain or prior surgery 4)Systemic infections 5)Poorly controlled hypertension or diabetes 6)Pathological fracture.
Investigators
Sathyanand V
SRM Medical College Hospital and Research Centre