Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach

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

Detailed Description
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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.

Official Title
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Minimally Invasive Calcaneal Fixation Via Sinus Tarsi Approach Vs Standard Lateral Extensile Approach in Calcaneal Fracture ( Randomized Controlled Trial )

Conditions
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Calcaneus Fracture

Intervention / Treatment
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* Procedure: Lateral extensile approach in calcaneal fractures fixation
* Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III. 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.). 3) open calcaneal fractures.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lateral extensile approach in calcaneal fractures fixation<br>Lateral extensile approach is the standard approach for intra-articular calcaneal fractures . | Procedure: Lateral extensile approach in calcaneal fractures fixation<br>* The standard extended lateral approach with L-shaped incision was made in this group, which originated vertically from 5 cm over lateral malleolus or the midpoint between the fibula and Achilles tendon and ended on the base of the fifth metatarsal . The incision is made directly to the bone at the corner to create a full-thickness flap. Attention must be paid to protect the sural nerve and peroneal tendons as well.<br>|
| Experimental: minimally invasive sinus tarsi approach in calc.fixation<br>Sinus tarsi approach become one of the most frequently applied minimally invasive approaches. | Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation<br>* An incision is made from the tip of the lateral malleolus toward the base of the fourth metatarsal bone. The incision lies in a plane between the superficial peroneal nerve and the sural nerve. Care is taken to bluntly dissect after the skin incision to protect the sural nerve or branches of the superficial peroneal nerve. By mobilizing the sinus tarsi fat pad dorsally, the incision was deepened. The extensor digitorum brevis muscle is sharply elevated off of the anterior process with the lateral root of the inferior extensor retinaculum and reflected dorsally and distally. The peroneus brevis and peroneus longus tendons are split, allowing exposure to the sinus tarsi and visualization of the posterior facet of the subtalar joint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological bohler angle | restoration of bohler of hind foot | baseline | 
| Wound complications | wound dehiscence, infection, etc | baseline | 
| FFI ( foot function index )for hind foot | foot function index | baseline | 
| Radiological gissane angle | Restoration of gissane angle of hind foot | intraoperative | 
| foot function | Degree of dorsiflexion , planter flexion , evertion , invertion | baseline | 
| Union rate | the percentage of union in each arm | baseline | 
| AOFAS( American association of foot and ankle score )for hind foot | american association foot and ankle score | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed before full weight bearing ( from 3 to 6 month ) | the time the patient take for full weight bearing , usually take from 3 to 6 months in each arm | baseline |