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

NCT06436365 | Completed

• 1 other identifier: MD-190-2020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Tibia Fracture

Outcome Measures

Primary Outcomes (1)

• Olerud Molander Ankle Score (OMAS)

  questionnaire assessing main nine aspects (daily life activity, pain, supports, swelling, jumping, stiffness, squatting, stair climbing, and running) with a maximum score of 100 indicated normal and minimal score of zero indicated totally impaired function. The score was graded by excellent (for scores between 91 to 100), good (scores between 61 to 90), fair (scores between 31 to 60), and poor (scores between 0 to 30)

  2 weeks

Secondary Outcomes (1)

• Complications

  2 weeks and 6 months

Study Arms (2)

expert IMN with poller screws

EXPERIMENTAL

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.

Procedure: Locking expert intramedullary nail fixation

distal tibial locked plate

ACTIVE COMPARATOR

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.

Procedure: Distal locked plate

Interventions

Locking expert intramedullary nail fixation 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.

expert IMN with poller screws

Distal locked plate 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.

distal tibial locked plate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital - Faculty of Medicine - Cairo University

Cairo, 11765, Egypt

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)