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临床试验/CTRI/2024/01/062137
CTRI/2024/01/062137尚未招募1 期

Comparative study to evaluate functional outcomes in calcaneal fractures managed by conservative versus operative methods.

Dr Shubham Verma1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年2月3日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Based on Aofas Score : Pain (40 points), Function

研究概览

简要总结

Calcaneus is a complex shaped bone in foot, consisting of a tuberosity, an anterior

process, and a medial process known as the sustentaculum tali. It articulates with talus via the

subtalar joint, which comprises a large posterior facet, a medial facet on the sustentaculum

and a small anterior facet. It articulates with cuboid forming calcaneocuboid joint.

Calcaneal fractures account for approximately 2% of all fractures, with displaced

intra- articular fractures comprising 60% to 75% of these injuries. Of patients with calcaneal

fractures, 10% have associated spine fractures and 26% are associated with other extremity

injuries1. Most fractures of the calcaneus are typically the result of high-energy trauma, such

as a fall from a height or a motor vehicle accident. The clinical examination focuses on pain,

swelling, hematoma and deformity at the hindfoot. Active or passive inversion and eversion

of the foot are painful. The initial radiographic evaluation of the patient with a suspected

calcaneal fracture includes a lateral radiograph series. The lateral radiograph of the hindfoot

demonstrates two important angles: the tuber angle of Böhler and the crucial angle of

Gissane2. CT scanning has vastly improved the understanding of calcaneal fractures. CT

images are obtained in the axial, 30-degree semi-coronal, and sagittal planes. The coronal

views provide information about the articular surface of the posterior facet, the

sustentaculum, the overall shape of the heel, and the position of the peroneal and flexor

hallucis tendons. The articular fracture classification system of Sanders et al. is based on

images in the coronal plane

There is a broad consensus that the outcome of calcaneal fractures mainly is

determined by the degree of joint destruction at the time of injury. However, until recently,

limitations of radiologically obtainable information and the lack of a useful classification

system have prevented knowledgeable assessment, understanding, and comparison of fracture

patterns of the os calcis.

The most common classification system used for more than 3 decades was proposed

in 1952 by Essex-Lopresti. This classification was developed to describe intra-articular and

extra-articular fractures of the calcaneus. The extra-articular fractures may involve anterior

process, tuberosity, achilles tendon avulsion, and sustentacular fractures. The intra-articular

calcaneal fractures will be divided into two groups: tongue-type and joint depression-type

fractures. The simplicity of this classification led to its widespread use. A major disadvantage

of this classification system exists in that the joint depression-type fracture group comprises

too many different fracture patterns. This does not allow for a useful correlation between the

fracture classification and the ultimate clinical outcome

The introduction of CT was the turning point in the classification and treatment of

calcaneal fractures. Axial and coronal CT views of calcaneal fractures changed the focus

away from the Böhler angle and the undefinable joint destruction to the specific analysis of

the posterior facet and the calcaneocuboid joint.

Sanders et al. developed a classification system which divided the posterior facet into

three different columns. The fractures were subdivided according to the location of the

primary and additional fracture lines

Fractures of the calcaneus remain among the most challenging for the orthopaedic

surgeon. Nonoperative treatment consists of a supportive splint to allow dissipation of the

initial fracture hematoma, followed by conversion to a prefabricated fracture boot with the

ankle locked in neutral flexion to prevent an equinus contracture and an elastic compression

stocking-to-minimize dependent oedema. Early subtalar and ankle joint range-of-motion

exercises are initiated, and non-weight-bearing restrictions are maintained for approximately

10 to 12 weeks until the radiographic union is confirmed5

.

The majority of displaced, intra-articular fractures of the calcaneus can be effectively

treated via an Extensile lateral approach. For internal fixation most surgeons use a single

lateral plate that displays the anatomical features of the calcaneus, providing support to the

tuberosity, the thalamic portion with the posterior joint facet and the anterior process. Screw

placement within the plate can be facilitated with the use of polyaxial locking plate designs6

.

The options for treating intraarticular calcaneus fractures may be evaluated in four

groups : Conservative treatment, closed reduction percutaneous fixation, open reduction

internal fixation and primary subtalar arthrodesis, and mini open approaches with

percutaneous fixation

In cases of simple intra articular fractures (Type IIa as described by Sanders et al.)

with minor displacement (≤2 mm) of the posterior facet intra articular fracture, a successful

reduction is attainable with the semi open technique using small portals (small elevator via

stab incisions) and percutaneous fixation. In elderly patients with concomitant diseases and

soft tissue problems, operative options that are more appropriate than the use of extensile

surgery where the potential wound complications could be significant. Severe vascular

diseases, advanced diabetes, and a preinjury non ambulatory status are contraindications for

open reduction and internal fixation. In cases of severe comminution of the posterior facet

(Type IV of the classification described by Sanders et al.), an anatomic reduction of the joint

surface rarely is obtainable. In this situation, two options are applicable according to the skill

and experience of the surgeon: semi open reduction and percutaneous fixation to restore the

anatomic axis; or primary subtalar fusion, which requires extensile bone grafting from the

iliac crest

In view of the above available modalities of treatment and since no method is

declared ideal in literature and also as many times patients do not give consent for operative intervention, we would like to conduct a study comparing conservative and operative approach for management of calcaneal fractures.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All patients of 18 to 70 years of age, with calcaneal fractures requiring surgery (Sander’s Grade II, III, IV)less than 3 weeks old having normal bipedal gait prior to fracture will be included in the study.

排除标准

  • Calcaneal fractures with associated spinal injuries, peripheral vasculopathies, pathological fractures and patients not giving consent will be excluded from our study.

结局指标

主要结局

Based on Aofas Score : Pain (40 points), Function

时间窗: 6 Months

(50 points) , Alignment (10 points) and Modified Rowe Score : Pain (30 points) , Range of motion (20 points) , Gait (15 points) , Activities (20 points) , Work (15 points)

时间窗: 6 Months

次要结局

未报告次要终点

研究者

发起方
Dr Shubham Verma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shubham Verma

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences ,Rohtak

研究点 (1)

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