Clinical trial NCT06436365: Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures?
Official title: Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibia Fracture
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The authors performed a prospective randomized controlled trial by including 42 patients to compare expert IMN with poller screws (Group One including 21 patients) versus distal tibial locked plate (Group Two including 21 patients) in fixation of extra-articular distal tibial fractures. The study was conducted after obtaining clearance from the Scientific Board and the Ethical Committee and all patients signed informed consents before starting the study.
Primary purpose: TREATMENT

Brief summary: Distal tibial fracture management is difficult because of poor blood supply resulted from subcutaneous location. Therefore, the study aims to compare expert intramedullary nail (IMN) with poller screws to the distal tibial locked plate regarding operative and complications outcomes

Detailed description: Stabilization of the fractured segments is the main goal in fracture fixation which will help to achieve proper healing, fasten early mobility, and get the full function of the injured limb. The fractures may be managed conservatively or by fixation whether internal or external .

Tibial fractures are the most common long bone fractures because of their subcutaneous location which makes them more liable to trauma. They are more common in young males as they are related to sports and traffic accidents. Elderly people come in second place of tibial fractures because they are more likely to occur from simple falls. Proper surgical management of displaced tibial fracture will help in increasing bone stability with the surrounding tissue and improving the bone alignment which in turn fastens the early movement, increases overall function, and prevents prolonged bedridden.

Distal tibia fractures represent from 7% to 10% of all lower limb fractures. Basically, there is controversy over the use of the term "distal tibial fractures" Some authors use the term to describe the distal metaphyseal fractures as defined by one Muller square as Giannoudis 2015 et al. Others use distal tibial fractures to refer to distal shaft fractures (meta-diaphyseal region) from 4 to 11 centimeters starting from the plafond as Polat 2015 et al . Others use the term for both regions, describing them as " two muller squares" as Mauffrey 2012 et al.

Management of distal tibial fracture management is difficult especially in old patients with mature skeletons and without involvement of knee joint because of a fracture near the position to the ankle joint with decreased blood flow resulting from the subcutaneous anatomical location \[8\]. There are common fixation techniques performed in distal tibial fracture management like open reduction with internal fixation, intramedullary nail insertion (IMN), minimally invasive percutaneous plate osteosynthesis, and external fixation with limited open reduction and internal fixation.

Despite these different management methods achieving success in proper reduction and enhancing the stability and union, they were associated with disadvantages that need to be considered during the management plan which makes no single method ideally preferred for all combined bone and soft tissue distal tibial traumas. Therefore, studies should address all advantages, disadvantages, and the proper application of each method.

We aim in our study to compare expert IMN with poller screws to the distal tibial locked plates in the management of the short oblique distal tibial fractures regarding clinical outcomes, radiological findings, complications, and the need for a secondary operation.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature (18-60 years) male and female patients presented with short oblique fractures which were defined by a fracture with an oblique fracture line its an inclination equal to or greater than 30° with respect to the perpendicular to the axis of the tibia .

Exclusion Criteria:

* We excluded patients presented with other fracture patterns
* intraarticular distal tibial fractures, old fractures, infected fractures, open fractures, and pathological fractures.

Primary outcomes:
measure: Olerud Molander Ankle Score (OMAS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Complications
timeFrame: 2 weeks and 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Hospital - Faculty of Medicine - Cairo University
Study officials:
References: