Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach
- Conditions
- Calcaneus Fracture
- Interventions
- Procedure: Lateral extensile approach in calcaneal fractures fixationProcedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation
- Registration Number
- NCT04509895
- Lead Sponsor
- Assiut University
- Brief Summary
a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III.
- closed calcaneal fractures
- 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.).
- open calcaneal fractures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lateral extensile approach in calcaneal fractures fixation Lateral extensile approach in calcaneal fractures fixation Lateral extensile approach is the standard approach for intra-articular calcaneal fractures . minimally invasive sinus tarsi approach in calc.fixation Minimally invasive sinus tarsi approach in calcaneal fractures fixation Sinus tarsi approach become one of the most frequently applied minimally invasive approaches.
- Primary Outcome Measures
Name Time Method AOFAS( American association of foot and ankle score )for hind foot baseline american association foot and ankle score
- Secondary Outcome Measures
Name Time Method Time needed before full weight bearing ( from 3 to 6 month ) baseline the time the patient take for full weight bearing , usually take from 3 to 6 months in each arm
Radiological gissane angle Baseline Restoration of gissane angle of hind foot
Radiological bohler angle baseline restoration of bohler of hind foot
Union rate baseline the percentage of union in each arm
Wound complications baseline wound dehiscence, infection, etc
Trial Locations
- Locations (1)
AssiutU
🇪🇬Assiut, Egypt