Clinical trial NCT06521606: Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.
Official title: Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilon Fracture
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilon fractures are among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. The latter is widely agreed upon in the literature. In the present study, we contrasted the outcomes of these two approaches.

Detailed description: Pilon fractures are responsible for 1% of lower limb fractures and 5-7% of tibial fractures. The optimal treatment for these fractures has remained challenging and complicated despite significant advancements in recent years in the management of these fractures, mostly because of severely injured soft tissue, severe edema, and a high-energy fracture pattern. As a result, selecting an appropriate course of treatment is still debatable.

Early after the injury, the subcutaneous soft tissue and local skin condition determine whether a direct method and open reconstruction of the articular surface are safe. Early surgical treatment through a flimsy soft tissue envelope raises the possibility of wound complications, promotes infection, and may even result in limb amputation.

The idea of postponing the ultimate osteosynthesis till after the cutaneous condition has been improved came to the forefront in the 1990s. Adopted techniques stressed thorough soft-tissue care in conjunction with delayed definitive fixation to minimize additional damage to surrounding soft tissues. Both long- and short-term outcomes showed decreased surgical complications.

Pilon fractures result from two different force types that can either act individually or concurrently. The primary force is axial compression, resulting in the talus being driven into the tibial plafond; this frequently results in concomitant damage to the talar dome. The secondary force type is rotation, producing variable degrees of articular shearing and fracture fragment displacement. A clear distinction should be made between these two different forces because the relative contribution of each affects the severity of the fracture, soft tissue damage, and prognosis.

The medial fragment, which comprises the medial malleolus and the nearby weight-bearing segment, the Chaput or anterolateral fragment, and the Volkman or posterolateral fragment, typically with their ligamentous attachments intact, are the three variable yet predictable fragments that make up the most specific fracture pattern. Where the implant will be put and, eventually, the surgical approach(es) that will be employed is influenced by the position of the articular segments, the location of the fracture lines as they exit the cortex, and whether or not those parts are continuous with the intact tibial shaft.

The anterolateral quarter of the articular surface and the central corridor of the plafond apex are frequent locations for areas of comminution. As a result, in most patients, an anterior approach provides better access to comminution zones, and an anterolateral distal tibia plate may be employed to strengthen the comminution zone. Although they occur in various planes, the three primary fracture fragments (anterolateral, medial, and posterior) are not sufficiently fixed by a single plate. Most anterolateral plates are insufficiently designed to capture the medial fragment.

Therefore, Phillip Penny et al. stated: Given the wide range of pilon fractures in various patient populations, it is doubtful that a single plate could maintain a sufficient reduction. Hence, it may be best to use a combination of plating techniques to stabilize distal tibia fractures while reinforcing comminution areas.

The results of treating pilon fractures are generally still not satisfactory. Infections, non-union, delayed union, and soft tissue healing complications are common. These complications are mainly caused by the anatomical features of this region, which include limited soft tissue coverage and an insufficient blood supply. Another factor is that such fractures are frequently the result of violent accidents that severely bruise the skin, blood vessels, and muscles. Moreover, in almost two-thirds of cases, arthritis might develop after surgical intervention for pilon fractures.

This study aims to evaluate the feasibility, advantages, and disadvantages of temporary external fixation for pilon fractures and compare its outcomes with cases that will be managed with primary open reduction and internal fixation (ORIF).

Eligibility criteria: Inclusion Criteria:

1. Age cohort: adults older than 18 years and less than 70.
2. Sex: both sexes
3. Pilon fracture.

Exclusion Criteria:

1. Patients refused to join the study after explaining the risks and benefits.
2. Infected cases.
3. History of peripheral angiopathy and/or neuropathy in the injured leg.
4. Patients with open fractures.
5. Patients with compartment syndrome.
6. Patients with pathological fractures and associated knee ligament tears.

Primary outcomes:
measure: Primary open reduction and internal fixation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy-Cairo University- Faculty of Medicine
state: Manial
Study officials:
References: