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

NCT06521606 | Completed

• 1 other identifier: N-441-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary open reduction and internal fixation

  The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. In the original publication, the AOFAS Ankle-Hindfoot Score was described to be used for ankle replacement, ankle arthrodesis, ankle instability operations, subtalar arthrodesis, subtalar instability operations, talonavicular arthrodesis, calcaneocuboid arthrodesis, calcaneal osteotomy, calcaneus fracture, talus fracture and ankle fractures

  6 months

Study Arms (2)

temporary external fixation

EXPERIMENTAL

In our study, 15 patients were managed by the two stages protocol in which they underwent temporary external fixation, and after 7-21 days, they underwent open reduction and internal fixation. The patients were chosen according to the previous criteria; history taking, counselling, general and local examination, and radiological evaluation, and all laboratory investigations were ordered.

Procedure: Temporary external fixator

Primary open reduction and internal fixation

ACTIVE COMPARATOR

Reconstruction and fixation of the metaphyseal shell 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.

Procedure: Primary open reduction and internal fixation

Interventions

Primary open reduction and internal fixation PROCEDURE

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.

Primary open reduction and internal fixation

Temporary external fixator PROCEDURE

). 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.

temporary external fixation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age cohort: adults older than 18 years and less than 70.
• Sex: both sexes
• Pilon fracture.

You may not qualify if:

• Patients refused to join the study after explaining the risks and benefits.
• Infected cases.
• History of peripheral angiopathy and/or neuropathy in the injured leg.
• Patients with open fractures.
• Patients with compartment syndrome.
• Patients with pathological fractures and associated knee ligament tears.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Ainy-Cairo University- Faculty of Medicine

Cairo, Manial, 11956, Egypt

Location

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

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.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

EG (1)