Intra-articular FracturesNCT02446470
Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures
A study testing Sinus Tarsi approach and Extensile Lateral approach in people with Intra-articular Fractures, run by University of Tennessee at 1 site in United States.
Trial summary
This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures. It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-articular Fractures
- What is being tested?
- Sinus Tarsi approach and Extensile Lateral approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature patients ≥ 18 years of age
- Closed intra-articular calcaneus fractures
- Undergoing surgical fixation (CPT code 28415)
- Ability to understand and agree to informed consent
Who cannot join
- Patients < 18 years of age
- Open fractures
- Dislocations that require open reduction
- Previous calcaneus abnormality or injury
- Unable to understand or agree to informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Health System
Chattanooga, Tennessee, 37403
About this study
Official title: Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures
This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.
It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.
- Conditions
- Intra-articular Fractures
- Being tested
- Sinus Tarsi approach, Extensile Lateral approach
- Keywords
- calcaneus, fracture fixation, internal
- Medical subject headings
- Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus Tarsi approachProcedure or surgery
A straight incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal which centers the incision over the sinus tarsi. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis (EDB). The origin of EDB is identified and the muscle is released distal enough to fully visualize the fracture and articular surface of the calcaneus. Following exposure of the fracture and articular surface of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.
Extensile Lateral approachProcedure or surgery
An L-shaped incision overlying the lateral wall of the calcaneus will be made, followed by sharp dissection of soft tissues in line with the skin incision down to the periosteum. Effort will be made to identify and protect the sural nerve, as it commonly crosses the surgical field with this approach. The soft tissue flap is retracted as a single unit as subperiosteal dissection is performed. Following exposure of the lateral wall of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.
| Study group | Role | What they receive |
|---|---|---|
| Sinus Tarsi approach | Experimental | The Sinus Tarsi approach is the surgical approach for the incision. Receives: Procedure: Sinus Tarsi approach |
| Extensile Lateral approach | Active comparator | The Extensile Lateral approach is the surgical approach for the incision. Receives: Procedure: Extensile Lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complication rate
There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing.
Measured: approximately one year
Secondary outcomes (9)
Fracture healing
On radiographic and clinical exam
Measured: approximately one year
Rate of sural nerve injury
Measured: approximately one year
Rate of peroneal tendon injury
Measured: approximately one year
Change in operative time
Measured: one day
Rate of secondary surgery
Measured: approximately one year
Visual Analog Scale
Pain Score
Measured: approximately one year
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Functional Outcome Score
Measured: approximately one year
Foot Function Index
Functional Outcome Score
Measured: approximately one year
Short-Form 36 (SF-36) Health Survey
Functional Outcome Score
Measured: approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-articular FracturesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse F Doty, MD, Principal investigator, University of Tennessee College of Medicine Chattanooga/Erlanger Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446470
- Sponsor's protocol ID
- 15-026
- Status last verified
- Nov 2018
- First submitted
- 30 Apr 2015
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures
- ClinicalTrials.gov ID
- NCT02446470
- Acronym / sponsor ID
- 15-026
- Conditions
- Intra-articular Fractures
- Keywords
- calcaneus, fracture fixation, internal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 May 2015 (estimated)
- 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.
This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.
It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus Tarsi approach | Experimental | Procedure: Sinus Tarsi approachThe Sinus Tarsi approach is the surgical approach for the incision. |
| Extensile Lateral approach | Active comparator | Procedure: Extensile Lateral approachThe Extensile Lateral approach is the surgical approach for the incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletally mature patients ≥ 18 years of age
- Closed intra-articular calcaneus fractures
- Undergoing surgical fixation (CPT code 28415)
- Ability to understand and agree to informed consent
Key exclusion criteria (5 listed)
- Patients < 18 years of age
- Open fractures
- Dislocations that require open reduction
- Previous calcaneus abnormality or injury
- Unable to understand or agree to informed consent
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 |
|---|---|---|
| Sinus Tarsi approachA straight incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal which centers the incision over the sinus tarsi. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis (EDB). The origin of EDB is identified and the muscle is released distal enough to fully visualize the fracture and articular surface of the calcaneus. Following exposure of the fracture and articular surface of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern. | Procedure or surgery | Sinus Tarsi approach |
| Extensile Lateral approachAn L-shaped incision overlying the lateral wall of the calcaneus will be made, followed by sharp dissection of soft tissues in line with the skin incision down to the periosteum. Effort will be made to identify and protect the sural nerve, as it commonly crosses the surgical field with this approach. The soft tissue flap is retracted as a single unit as subperiosteal dissection is performed. Following exposure of the lateral wall of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern. | Procedure or surgery | Extensile Lateral approach |
Primary outcome
Wound complication rate
Time frame: approximately one year
There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing.
9 secondary outcomes
Fracture healing
Time frame: approximately one year
Rate of sural nerve injury
Time frame: approximately one year
Rate of peroneal tendon injury
Time frame: approximately one year
Change in operative time
Time frame: one day
Rate of secondary surgery
Time frame: approximately one year
Visual Analog Scale
Time frame: approximately one year
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Time frame: approximately one year
Foot Function Index
Time frame: approximately one year
Short-Form 36 (SF-36) Health Survey
Time frame: approximately one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Jesse F Doty, MD principal investigator
University of Tennessee College of Medicine Chattanooga/Erlanger Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus Tarsi approach and Extensile Lateral approach in people with Intra-articular Fractures, run by University of Tennessee at 1 site in United States.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Nov 2018. 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 United States. 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?
Results are not available in the source record.
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?
Wound complication rate (time frame: approximately one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.