Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05504304 |
| Other study ID # |
MD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2019 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Fracture calcaneus accounts for up to 2% of all fractures. 75% of calcaneal fractures are
displaced intra-articular fractures and historically have been associated with poor
functional outcomes.
When the talus applies an axial loading to the posterior facet, shear forces result in a
primary fracture line between medial (sustentaculum tali) and lateral part of the calcaneus.
As the axial force continues, a secondary fracture line will develop. According to the
relation of the secondary fracture line's exit to insertion of tendo-achilis Essex-Lopresti
classified that into two types joint depression and tongue.
Numerous classifications exist in the literature but that by Sanders is the most prevalent
and best suited for clinical practice and for research purposes.
Sanders in his clinical trials found that as the number of articular fragments- based on
axial and coronal CT scan cuts with the widest undersurface of the posterior facet of the
talus- increase, the results and prognosis worsen.
Up to 73% in the sanders type IV fractures eventually leads to subtalar fusion to manage
post-traumatic subtalar arthritis. They are 5.5 times more likely to require subtalar
arthrodesis than Sanders II fractures. Second surgeries increase the cost of management and
delay the return of level of function for the patient.
Some authors advocate that the fractures with a higher Sanders classification demonstrated no
difference between operative and non-operative treatment. However, careful stratification of
the patients may show better outcomes after surgical intervention in some groups.
There is no consensus about how to manage calcaneal fractures but we can divide management
into four broad categories: Non-operative, Open reduction and internal fixation, Minimally
invasive reduction and fixation and finally Primary ORIF and subtalar arthrodesis.
Our trial was conducted to add to the current evidence and our main questions are: does
initial reduction and fixation of comminuted displaced intra-articular Sanders type IV
calcaneal fractures matter in subtalar fusion?
Description:
Randomization: patients presented to clinic or emergency room with recent (30 days or less)
Sanders type IV intra-articular calcaneal fractures will be included in group A. Patients
referred to our clinic (from other surgeons or hospitals) with old (more than three months)
Sanders type IV intra-articular calcaneal fractures will form group B.
Group A: open reduction and internal fixation plus primary subtalar arthrodesis.
Group B: conservative management for at least three months then calcaneoplasty and late
subtalar arthrodesis.
Ethical Considerations: Will be followed by obtaining the hospital Research Ethics Committee
approval and written informed consents from the patients.
Intervention:
All patients were subjected to the same initial treatment with below knee slab, limb
elevation and analgesics.
Patient in group A will be scheduled to surgery after resolution of the edema and appearance
of wrinkle sign.
They will be anesthetized and tourniquet will be applied over the thigh. Lateral position and
lateral extensile approach will be used. A full flap will be developed by subperiosteal
dissection with protection of sural nerve and peroneal tendons. Three k-wires will be
inserted in fibula, lateral surface of talus and cuboid bones as retractors.
A 4 mm schanz will be inserted in the calcaneal tuberosity from lateral side to control varus
and to restore calcaneal height. Lateral wall of the calcaneus will be lifted keeping it
attached inferiorly. Articular surfaces of inferior surface of the talus and posterior facet
of the calcaneus will be debrided thoroughly and drilled by 2 mm k-wire. tricortical iliac
bone autograft will be inserted the subtalar joint. A lateral nonlocked plate will be applied
to reduce the lateral wall blow out and broadening then fixation by two cannulated partially
threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by
fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee
slab will be applied and non-weight bearing for six weeks.
Group B patients will be assessed upon 1st clinic visit. After at least three months patients
will be scheduled for subtalar arthrodesis. A new preoperative ankle CT scan will be done.
Patients will be anesthetized and tourniquet will be applied over the thigh. Lateral position
and lateral extensile approach will be used. A full flap will be developed by subperiosteal
dissection with protection of sural nerve and peroneal tendons. Three k-wires will be
inserted in fibula, lateral surface of talus and cuboid bones as retractors.
Lateral wall and plantar exostosis will be resected. Articular surfaces of inferior surface
of the talus and posterior facet of the calcaneus will be debrided thoroughly and drilled by
2 mm k-wire. Hind foot deformity (mostly varus) will be corrected through the subtalar joint
manually and checked clinically. Loss of calcaneal height will be corrected by tricortical
iliac bone autograft to distract the subtalar joint then fixation by two cannulated partially
threaded 7.3 screws from the calcaneal tuberosity to the talus. We will check position by
fluoroscopy then closure in two layers (subcutaneous and skin) after homeostasis. Below knee
slab will be applied and non-weight bearing for six weeks.
Post operatively, both groups will be followed after intervention every two weeks for two
months then every three months for one year. Outcomes will be assessed using questionnaires
in our clinic at six months and one-year visits.
