JMIR Publications

ABSTRACT

Background:

Distal third tibial fractures are challenging to manage owing to the subcutaneous anteromedial border of the tibia, its tenuous periosteal vascularity, and the proximity of the fracture to the ankle joint. Conventional open reduction and internal fixation (ORIF) is associated with wound breakdown, deep surgical site infection, and delayed union at this anatomical level. Minimally invasive plate osteosynthesis (MIPO) using a locking compression plate (LCP) preserves the fracture haematoma and periosteal blood supply by avoiding direct fracture-site exposure, and has been shown in multiple prospective and comparative series to yield high union rates with an acceptable complication profile.

Objective:

This study aims to describe the functional and radiological outcomes of closed distal third tibial fractures (AO/OTA types A, B, and C1) treated with MIPO-LCP in an Indian tertiary care setting. The study is not designed as a superiority or comparative effectiveness trial; its objectives are descriptive and hypothesis-generating.

Methods:

This is a single-centre, single-arm, prospective observational cohort study (Level IV evidence) to be conducted at rural tertiary center, India, over 24 months from May 2026 to April 2028. Thirty adult patients aged 18 to 80 years with closed AO/OTA type A or type B distal third tibial fractures are to be enrolled consecutively. The primary outcome is the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score at six months, administered by an independent assessor. Secondary outcomes include the Olerud-Molander Ankle Score (OMAS), time to radiological fracture union assessed using the Radiographic Union Scale for Tibia (RUST), incidence of complications, and time to full weight-bearing. Regression analysis is planned for identification of predictors of functional outcome and union. Follow-up is scheduled at six weeks, three months, six months, and twelve months after surgery; twelve-month AOFAS and OMAS scores constitute secondary durability endpoints.

Results:

As of the protocol submission date (April 2026), the study has received institutional ethics approval (8 July 2025) and CTRI registration (21 April 2026). Patient enrolment is scheduled to commence on 1 May 2026. Data collection is projected to complete by April 2028, with final 12-month follow-up anticipated by April 2029. Results are expected to be available for publication by December 2029.

Conclusions:

This prospective observational study will provide high-quality descriptive data on functional and radiological outcomes of MIPO-LCP for distal third tibial fractures in an Indian tertiary care setting. The findings will inform clinical decision-making and generate hypotheses for future comparative trials. Clinical Trial: CTRI/2026/04/108996 (Registered prospectively, 21 April 2026)