CTRI

1. Proposed topic of research:

A randomized comparative study of the efficacy of functional recovery of individuals following standard open reduction internal fixation vs MIROS fixation in NEER’S 2 and 3 parts proximal humeral fractures attended in a tertiary care centre.

2. Objective of proposed research:

To compare the overall functional recovery of results in patients with Neer’s 2- and 3-part proximal humerus fractures treated with standard open reduction and internal fixation (ORIF) versus MIROS fixation.

3. Background of present study:

Proximal humerus fractures are among the most common osteoporotic fractures in the elderly, accounting for approximately 5–6% of all adult fractures, with increasing incidence due to ageing populations worldwide. Management of these fractures remains challenging, especially in complex or displaced cases, where achieving stable fixation with minimal soft tissue disruption is critical for optimal recovery. Traditional open reduction and internal fixation techniques, though effective, are often associated with higher rates of complications such as infection, avascular necrosis, and prolonged rehabilitation. The Minimally Invasive Reduction and Osteosynthesis System (MIROS) is a relatively newer percutaneous fixation method designed to reduce surgical trauma, preserve vascularity, and promote early mobilisation. Preliminary studies suggest that MIROS offers promising functional outcomes with fewer complications, particularly in elderly or medically compromised patients.

However, comprehensive evaluation of its clinical effectiveness and functional recovery in diverse patient populations is still limited, warranting further investigation.

4. Methodology:

This randomised controlled trial (longitudinal interventional study) will be conducted in the Department of Orthopaedics at R.G. Kar Medical College and Hospital. A total of 40 patients presenting with proximal humerus fractures and treated with the Minimally Invasive Reduction and Osteosynthesis System (MIROS) will be selected consecutively during the study period. Relevant demographic, clinical, and radiological data will be recorded. Functional outcomes will be assessed using validated scoring systems such as the

Constant Murley Score and/or DASH score during follow-up visits. The collected data will be analysed to evaluate the functional recovery and complication rates associated with MIROS in the management of proximal humerus fractures. Patient allocation by random selection using the Stratified Random Sampling method.

5. Expected outcome:

The expected outcome of the study is that patients with proximal humerus fractures treated with MIROS will demonstrate favourable healing of fracture and soft tissue with early recovery of painless range of motion of the shoulder with or without minimal complications. The study also anticipates a positive correlation between early postoperative functional scores and long-term clinical outcomes.