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

NCT06521606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-26

No results posted yet for this study

Summary

Pilon fractures are among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. The latter is widely agreed upon in the literature. In the present study, we contrasted the outcomes of these two approaches.

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.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-01
Completion
2024-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521606 on ClinicalTrials.gov