Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 1, 2021

Study Completion Date

January 1, 2024

Conditions
Pilon Fracture
Interventions
PROCEDURE

Primary open reduction and internal fixation

The percutaneous pin was used to manipulate the fragment to achieve reduction; then, a lag screw fixation was done by antegrade technique through a stab incision posteriorly and directly over the fragment. The medial fragment was fixed after the reconstruction of the tibial articular surface to facilitate the anatomic reduction of joint fragments. Again, an image intensifier was used to check the reduction and fixation and to avoid errors of penetration of the joint by screws, malalignment, and inadequate reconstruction of the articular surface; then, the necessary changes were adjusted and made. Wide bone defects in six cases of the primary ORIF cohort and eight cases of the two-stage cohort were packed by corticocancellous iliac bone grafts.

PROCEDURE

Temporary external fixator

). Schanz screws with a 6 mm diameter were used to simulate the gripping points on the tibial crest at the proximal metaphyseal or diaphyseal level and on the medial side of the heel bone. This latter pin was carefully inserted medial to lateral, ensuring the starting point is two cm anterior and proximal to the posteroinferior aspect of the calcaneal tuberosity to avoid injury to the medial neurovascular bundle and prevent injury iatrogenic fracture. Such posterior pin placement better balances the deforming forces of the powerful triceps surae muscles. To prevent equinus contracture and provide additional stability. Medial and lateral side rods were then connected to the pins. Manual traction was applied to the exoskeleton base during ligamentotaxis to distract the joint and realign the fracture; this distraction was then kept in place by tightening the clamps.

Trial Locations (1)

11956

Kasr Al Ainy-Cairo University- Faculty of Medicine, Cairo

All Listed Sponsors
lead

Kasr El Aini Hospital

OTHER

NCT06521606 - Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial. | Biotech Hunter | Biotech Hunter