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Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach

Primary Purpose

Calcaneus Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lateral extensile approach in calcaneal fractures fixation
Minimally invasive sinus tarsi approach in calcaneal fractures fixation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneus Fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • AssiutURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lateral extensile approach in calcaneal fractures fixation

minimally invasive sinus tarsi approach in calc.fixation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2020
Last Updated
August 30, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04509895
Brief Title
Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach
Official Title
Minimally Invasive Calcaneal Fixation Via Sinus Tarsi Approach Vs Standard Lateral Extensile Approach in Calcaneal Fracture ( Randomized Controlled Trial )
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneus Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lateral extensile approach in calcaneal fractures fixation
Arm Type
Experimental
Arm Description
Lateral extensile approach is the standard approach for intra-articular calcaneal fractures .
Arm Title
minimally invasive sinus tarsi approach in calc.fixation
Arm Type
Experimental
Arm Description
Sinus tarsi approach become one of the most frequently applied minimally invasive approaches.
Intervention Type
Procedure
Intervention Name(s)
Lateral extensile approach in calcaneal fractures fixation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive sinus tarsi approach in calcaneal fractures fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiological bohler angle
Description
restoration of bohler of hind foot
Time Frame
baseline
Title
Wound complications
Description
wound dehiscence, infection, etc
Time Frame
baseline
Title
FFI ( foot function index )for hind foot
Description
foot function index
Time Frame
baseline
Title
Radiological gissane angle
Description
Restoration of gissane angle of hind foot
Time Frame
intraoperative
Title
foot function
Description
Degree of dorsiflexion , planter flexion , evertion , invertion
Time Frame
baseline
Title
Union rate
Description
the percentage of union in each arm
Time Frame
baseline
Title
AOFAS( American association of foot and ankle score )for hind foot
Description
american association foot and ankle score
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Time needed before full weight bearing ( from 3 to 6 month )
Description
the time the patient take for full weight bearing , usually take from 3 to 6 months in each arm
Time Frame
baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter M shehata
Phone
+201205175861
Email
petermamdouh05@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Mohamed, lecturer
Phone
+201007788699
Email
Amr.a.mohamed@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wael Y Eladly, professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
AssiutU
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
8472475
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.
Results Reference
result
Citation
Cohen Z, Volpin G, Shtarker H. Surgical treatment of displaced calcaneal fractures Europian Instructional lectures, EFORT, 2011; 11: 199-214.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
20307476
Citation
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.
Results Reference
result
PubMed Identifier
25441282
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.2014.09.003. Epub 2014 Oct 18.
Results Reference
result
PubMed Identifier
24281853
Citation
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.
Results Reference
result
PubMed Identifier
25886471
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.
Results Reference
result
PubMed Identifier
24607889
Citation
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.
Results Reference
result
PubMed Identifier
24103451
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.
Results Reference
result

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Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach

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