Calcaneus FractureNCT04509895
Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach
A study testing Lateral extensile approach in calcaneal fractures fixation and Minimally invasive sinus tarsi approach in calcaneal fractures fixation in people with Calcaneus Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Calcaneus Fracture
- What is being tested?
- Lateral extensile approach in calcaneal fractures fixation and Minimally invasive sinus tarsi approach in calcaneal fractures fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III.
- closed calcaneal fractures
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Calcaneal Fixation Via Sinus Tarsi Approach Vs Standard Lateral Extensile Approach in Calcaneal Fracture ( Randomized Controlled Trial )
a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.
Read the 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.
- Conditions
- Calcaneus Fracture
- Being tested
- Lateral extensile approach in calcaneal fractures fixation, Minimally invasive sinus tarsi approach in calcaneal fractures fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral extensile approach in calcaneal fractures fixationProcedure or surgery
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 fixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| lateral extensile approach in calcaneal fractures fixation | Experimental | Lateral extensile approach is the standard approach for intra-articular calcaneal fractures . Receives: 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. Receives: Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS( American association of foot and ankle score )for hind foot
american association foot and ankle score
Measured: baseline
Secondary outcomes (5)
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
Measured: baseline
Radiological bohler angle
restoration of bohler of hind foot
Measured: baseline
Wound complications
wound dehiscence, infection, etc
Measured: baseline
Radiological gissane angle
Restoration of gissane angle of hind foot
Measured: Baseline
Union rate
the percentage of union in each arm
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2021
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Calcaneus FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peter mamdouh shehata, Assiut University
- Investigators
- wael Y Eladly, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509895
- Sponsor's protocol ID
- calcaneal fractures
- Status last verified
- Apr 2024
- First submitted
- 6 Aug 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8472475Cohen Z, Volpin G, Shtarker H. Surgical treatment of displaced calcaneal fractures Europian Instructional lectures, EFORT, 2011; 11: 199-214.
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.
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.
PubMed 20307476Cao 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.
PubMed 25441282Backes 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.
PubMed 24281853Yeo 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.
PubMed 25886471Xia 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.
PubMed 24607889Xia 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.
PubMed 24103451
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Calcaneal Fixation Via Sinus Tarsi Approach Vs Standard Lateral Extensile Approach in Calcaneal Fracture ( Randomized Controlled Trial )
- ClinicalTrials.gov ID
- NCT04509895
- Acronym / sponsor ID
- calcaneal fractures
- Conditions
- Calcaneus Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral extensile approach in calcaneal fractures fixation | Experimental | Procedure: Lateral extensile approach in calcaneal fractures fixationLateral extensile approach is the standard approach for intra-articular calcaneal fractures . |
| minimally invasive sinus tarsi approach in calc.fixation | Experimental | Procedure: Minimally invasive sinus tarsi approach in calcaneal fractures fixationSinus tarsi approach become one of the most frequently applied minimally invasive approaches. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III.
- closed calcaneal fractures
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral extensile approach in calcaneal fractures fixationThe 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. | Procedure or surgery | lateral extensile approach in calcaneal fractures fixation |
| Minimally invasive sinus tarsi approach in calcaneal fractures fixationAn 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. | Procedure or surgery | minimally invasive sinus tarsi approach in calc.fixation |
Primary outcome
AOFAS( American association of foot and ankle score )for hind foot
Time frame: baseline
american association foot and ankle score
5 secondary outcomes
Time needed before full weight bearing ( from 3 to 6 month )
Time frame: baseline
Radiological bohler angle
Time frame: baseline
Wound complications
Time frame: baseline
Radiological gissane angle
Time frame: Baseline
Union rate
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 8472475Sanders 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 publicationCohen Z, Volpin G, Shtarker H. Surgical treatment of displaced calcaneal fractures Europian Instructional lectures, EFORT, 2011; 11: 199-214.
- Results publicationSanders 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 publication: PubMed 20307476Mitchell 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 publication: PubMed 25441282Cao 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 publication: PubMed 24281853Backes 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 publication: PubMed 25886471Yeo 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 publication: PubMed 24607889Xia 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 publication: PubMed 24103451Xia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wael Y Eladly, professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral extensile approach in calcaneal fractures fixation and Minimally invasive sinus tarsi approach in calcaneal fractures fixation in people with Calcaneus Fracture, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS( American association of foot and ankle score )for hind foot (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509895, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.