Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach

NCT04509895 | Completed

• 1 other identifier: calcaneal fractures
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Calcaneus Fracture

Outcome Measures

Primary Outcomes (1)

• AOFAS( American association of foot and ankle score )for hind foot

  american association foot and ankle score

  baseline

Secondary Outcomes (5)

• Time needed before full weight bearing ( from 3 to 6 month )

  baseline

• Radiological bohler angle

  baseline

• Wound complications

  baseline

• Radiological gissane angle

  Baseline

• Union rate

  baseline

Study Arms (2)

lateral extensile approach in calcaneal fractures fixation

EXPERIMENTAL

Lateral extensile approach is the standard approach for intra-articular calcaneal fractures .

Procedure: Lateral extensile approach in calcaneal fractures fixation

minimally invasive sinus tarsi approach in calc.fixation

EXPERIMENTAL

Sinus tarsi approach become one of the most frequently applied minimally invasive approaches.

Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation

Interventions

Lateral extensile approach in calcaneal fractures fixation PROCEDURE

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.

lateral extensile approach in calcaneal fractures fixation

Minimally invasive sinus tarsi approach in calcaneal fractures fixation PROCEDURE

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.

minimally invasive sinus tarsi approach in calc.fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

AssiutU

Asyut, Egypt

Location

Related Publications (9)

• 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.

  PMID: 8472475 RESULT

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

  RESULT

• 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.

  RESULT

• 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.

  PMID: 20307476 RESULT

• 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.2014.09.003. Epub 2014 Oct 18.

  PMID: 25441282 RESULT

• 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/s00264-013-2181-1. Epub 2013 Nov 27.

  PMID: 24281853 RESULT

• 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.

  PMID: 25886471 RESULT

• 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 trial. Int J Surg. 2014;12(5):475-80. doi: 10.1016/j.ijsu.2014.03.001. Epub 2014 Mar 5.

  PMID: 24607889 RESULT

• 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.

  PMID: 24103451 RESULT

Study Officials

• wael Y Eladly, professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 12, 2020
• Study Start: October 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

EG (1)