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Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach

A

Assiut University

Status

Completed

Conditions

Calcaneus Fracture

Treatments

Procedure: Lateral extensile approach in calcaneal fractures fixation
Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT04509895
calcaneal fractures

Details and patient eligibility

About

a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.

Full description

Calcaneal fracture occurred in about 2% of patients; they represented almost 60% of all tarsal fractures.

Calcaneal fractures are caused by high velocity Force to the heel, mostly vehicle accident or fall from height. There are many factors affect the fracture pattern: age of the patient, weight , type of fall . Male patients predominated (75%) and younger than 50 years. In most cases, these fractures are bilateral and conjoined with lumbar spine fractures.

According to the result of computed tomography (CT) scanning. The calcaneal fractures can be classified into 4 categories, among which the SANDERS TYPE Ⅱ and Ⅲ fractures are the most common types.2 Thus the development of effective and safe treatment strategies for these two fracture types has always been an issue among orthopedic surgeons.

The treatment of intra-articular calcaneal fractures has always been controversial. Currently open reduction and internal fixation through L-Shape extensile incision has been considered as the gold standard surgical therapy for calcaneal fractures. This approach provide a large view to expose the fracture, allowing accurate reduction of the deformed posterior facet and convenient placement of the plate to achieve stable fixation. Postoperatively, plaster cast is worn for 2 weeks, walking with the crutches for additional 8-12 weeks is prescribed, and return to work is achieved after 6-9 months. However, the high incidence (approximately 30%) of complications associated with this approach, including wound dehiscence and deep infection , remain a non-negligible problem .

To lower the wound complications , a minimally invasive approaches has been introduced such as percutaneously applied distraction systems K-wires or screw fixation of intra-articular fractures , the use of elizarov device , percutaneous arthroscopy assisted osteosynthesis and Sinus Tarsi approaches . The sinus tarsi approach has become one of the most frequently applied minimally invasive approaches because of its ability to provide adequate exposure for the posterior facet, the anterolateral fragment and the lateral wall. Wound complication rate with this approach have been reported to range from 0% to 15.4% . Nevertheless, the poor visualization of the lateral wall of the calcaneus through this small incision makes it difficult to insert the conventional plate for obtaining a stable fixation. Thus, the development of a plate that is adaptable to the anatomic characteristics of the calcaneus and sinus tarsi approach is important.

Enrollment

225 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III.
  2. closed calcaneal fractures

Exclusion criteria

  • 1)patients with calcaneal fractures classification according to sanders classification , are sanders type I or IV 2)patients who have systemic comorbidity as( cardic ,diabetec ,cirrhotic patients, etc.) or smokers or local lesion as (blisters,vasculopathy , swelling etc.).
  1. open calcaneal fractures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

225 participants in 2 patient groups

lateral extensile approach in calcaneal fractures fixation
Experimental group
Description:
Lateral extensile approach is the standard approach for intra-articular calcaneal fractures .
Treatment:
Procedure: Lateral extensile approach in calcaneal fractures fixation
minimally invasive sinus tarsi approach in calc.fixation
Experimental group
Description:
Sinus tarsi approach become one of the most frequently applied minimally invasive approaches.
Treatment:
Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation

Trial contacts and locations

1

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Central trial contact

Amr A Mohamed, lecturer; Peter M shehata

Data sourced from clinicaltrials.gov

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