Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach

Calcaneus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509895
• Other study ID #: calcaneal fractures
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.).

3) open calcaneal fractures.

Related Conditions & MeSH terms

• Calcaneus Fracture
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Egypt	AssiutU	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Backes M, Schepers T, Beerekamp MS, Luitse JS, Goslings JC, Schep NW. Wound infections following open reduction and internal fixation of calcaneal fractures with an extended lateral approach. Int Orthop. 2014 Apr;38(4):767-73. doi: 10.1007/s00264-013-2181 — View Citation

Cao L, Weng W, Song S, Mao N, Li H, Cai Y, Zhou Q Jr, Su J. Surgical treatment of calcaneal fractures of Sanders type II and III by a minimally invasive technique using a locking plate. J Foot Ankle Surg. 2015 Jan-Feb;54(1):76-81. doi: 10.1053/j.jfas.2014 — View Citation

Cohen Z, Volpin G, Shtarker H. Surgical treatment of displaced calcaneal fractures Europian Instructional lectures, EFORT, 2011; 11: 199-214.

Mitchell MJ, McKinley JC, Robinson CM. The epidemiology of calcaneal fractures. Foot (Edinb). 2009 Dec;19(4):197-200. doi: 10.1016/j.foot.2009.05.001. — View Citation

Sanders R, Fortin P, DiPasquale T, Walling A. Operative treatment in 120 displaced intraarticular calcaneal fractures. Results using a prognostic computed tomography scan classification. Clin Orthop Relat Res. 1993 May;(290):87-95. — View Citation

Sanders RW, Clare MP. Fractures of the calcaneus in the Surgery of the Foot and Ankle, Coughlin MJ, Mann RA, Saltzman CL. (eds), Mosby Elsevier 8th ed. 2007; 2017-2073.

Xia S, Lu Y, Wang H, Wu Z, Wang Z. Open reduction and internal fixation with conventional plate via L-shaped lateral approach versus internal fixation with percutaneous plate via a sinus tarsi approach for calcaneal fractures - a randomized controlled tri — View Citation

Xia S, Wang X, Lu Y, Wang H, Wu Z, Wang Z. A minimally invasive sinus tarsi approach with percutaneous plate and screw fixation for intra-articular calcaneal fractures. Int J Surg. 2013;11(10):1087-91. doi: 10.1016/j.ijsu.2013.09.017. Epub 2013 Oct 5. — View Citation

Yeo JH, Cho HJ, Lee KB. Comparison of two surgical approaches for displaced intra-articular calcaneal fractures: sinus tarsi versus extensile lateral approach. BMC Musculoskelet Disord. 2015 Mar 19;16:63. doi: 10.1186/s12891-015-0519-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS( American association of foot and ankle score )for hind foot	american association foot and ankle score	baseline
Secondary	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
Secondary	Radiological bohler angle	restoration of bohler of hind foot	baseline
Secondary	Wound complications	wound dehiscence, infection, etc	baseline
Secondary	Radiological gissane angle	Restoration of gissane angle of hind foot	Baseline
Secondary	Union rate	the percentage of union in each arm	baseline