An interventional study of Lateral extensile approach in calcaneal fractures fixation and Minimally invasive sinus tarsi approach in calcaneal fractures fixation in Calcaneus Fracture, sponsored by Assiut University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 225 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Lateral extensile approach is the standard approach for intra-articular calcaneal fractures .
Procedure: Lateral extensile approach in calcaneal fractures fixation
Sinus tarsi approach become one of the most frequently applied minimally invasive approaches.
Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation
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.
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.
AOFAS( American association of foot and ankle score )for hind foot
american association foot and ankle score
Time frame: baseline
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
Time frame: baseline
Radiological bohler angle
restoration of bohler of hind foot
Time frame: baseline
Wound complications
wound dehiscence, infection, etc
Time frame: baseline
Radiological gissane angle
Restoration of gissane angle of hind foot
Time frame: Baseline
Union rate
the percentage of union in each arm
Time frame: baseline
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Assiut University