Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures?

NCT ID: NCT06436365

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-01

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.

Conditions

Tibia Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

expert IMN with poller screws

Twenty-one patients underwent IMN fixation by placing in a supine position with the knee flexed at 90 degrees above the radiolucent table to enable intraoperative imaging and a bolster was put below the thigh to enable knee flexion up to 110 degrees. Multiple interlocking screws were inserted in the expert nail which costed the double compared to the ordinary nail.

Group Type: EXPERIMENTAL

Locking expert intramedullary nail fixation

Intervention Type: PROCEDURE

the fracture was reduced to enable the insertion of the guide wire to restore the rotation, length, and angulation. Poller screws were used as control deformity by narrowing the medullary canal and were inserted on the deformity concave side between the nail and bone cortex. A ball-ended guidewire was placed through the entry point to the tibial canal and then to the tibial fracture site under the guidance of fluoroscopy. The guide wire should be inserted centrally within the distal segment on both lateral and anteroposterior views and be far about 1 to 0.5 centimeters from the ankle joint. Reamers with deep fluted and small diameters were used slowly to increase the diameter to reach 0.5 mm till the cortical chatter.

The nail was inserted by attachment of insertion device and locking of the proximal screw to the nail by directing its apex posteriorly. The nail insertion was done by flexing the knee to prevent any patellar impingement.

distal tibial locked plate

patients underwent distal locked plates by placing in a supine position and raising of the contralateral iliac crest which enhanced the rotation and made it easier for medial side access. Thigh was elevated and torniquet was put up to 300 mmHg. By reduction preservation, proximal screws were inserted by small incisions which was followed by insertion of the remained distal screws.

Group Type: ACTIVE_COMPARATOR

Distal locked plate

Intervention Type: PROCEDURE

Cobb dissector was used in creation extra-periosteal subcutaneous tunnel for gentle introduction of a proper plate which was determined by choosing appropriate size and level guided by imaging which helped in prevention of any periosteal damage. Manual closed reduction was performed using the percutaneous clamps. Distal screws were positioned as the following, one was inserted above the medial malleolus, another one was inserted right and below the fracture, and the other screws were inserted to help in anatomical plate positioning. By reduction preservation, proximal screws were inserted by small incisions which was followed by insertion of the remained distal screws.

Interventions

Locking expert intramedullary nail fixation

the fracture was reduced to enable the insertion of the guide wire to restore the rotation, length, and angulation. Poller screws were used as control deformity by narrowing the medullary canal and were inserted on the deformity concave side between the nail and bone cortex. A ball-ended guidewire was placed through the entry point to the tibial canal and then to the tibial fracture site under the guidance of fluoroscopy. The guide wire should be inserted centrally within the distal segment on both lateral and anteroposterior views and be far about 1 to 0.5 centimeters from the ankle joint. Reamers with deep fluted and small diameters were used slowly to increase the diameter to reach 0.5 mm till the cortical chatter.

The nail was inserted by attachment of insertion device and locking of the proximal screw to the nail by directing its apex posteriorly. The nail insertion was done by flexing the knee to prevent any patellar impingement.

Intervention Type: PROCEDURE

Distal locked plate

Cobb dissector was used in creation extra-periosteal subcutaneous tunnel for gentle introduction of a proper plate which was determined by choosing appropriate size and level guided by imaging which helped in prevention of any periosteal damage. Manual closed reduction was performed using the percutaneous clamps. Distal screws were positioned as the following, one was inserted above the medial malleolus, another one was inserted right and below the fracture, and the other screws were inserted to help in anatomical plate positioning. By reduction preservation, proximal screws were inserted by small incisions which was followed by insertion of the remained distal screws.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Omar Sabry

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy Hospital - Faculty of Medicine - Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-190-2020

Identifier Type: -

Identifier Source: org_study_id