Minimally Invasive Procedure Versus Conservative Treatment in the Management of Calcaneal Joint Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- To show a significant difference in favour of minimally invasive surgical treatment compared with orthopaedic treatment for displaced articular fractures of the calcaneus.
研究概览
简要总结
Calcaneal fractures, which affect the heel bone, are the most common type of tarsal fractures and often occur in young people, leading to long recovery times and significant social and economic consequences. Traditional treatments include either non-surgical methods, like immobilizing the foot in a cast, or open surgery, which involves a large incision to fix the bone with plates. However, open surgery has a high complication rate, including issues with wound healing. Recent advances have introduced minimally invasive surgical techniques, which use smaller incisions and have shown better results with fewer complications. This study aims to compare two treatment options for displaced calcaneal fractures: a minimally invasive surgery group and a non-surgical treatment group using a plaster boot. The goal is to determine whether minimally invasive surgery provides better outcomes for patients, such as faster recovery, fewer complications, and improved long-term function, to guide future treatment practices. Thus, this is a prospective, randomised comparative study of the management of articular fractures of the calcaneus: conservative treatment versus minimally invasive surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or over
- •Patient with a posterior articular fracture of the calcaneus Sanders II to IV, less than 15 days old
- •Patient affiliated to a social security scheme,
- •Patient having given written consent following written and oral information.
排除标准
- •Patient with open calcaneal fracture
- •Patient with bilateral calcaneal fracture
- •Patient with extreme varus or valgus impingement of the fibula
- •Patient with associated talar, tibial, femoral and/or pelvic fracture or associated spinal cord injury.
- •Patient unsuitable for loco-regional anaesthesia (LRA).
- •Patient with neuro-psychiatric disorders resulting in an inability to follow a post-surgical or post-immobilisation rehabilitation protocol.
- •Pregnant women
- •Patient protected by law under guardianship or curatorship, or unable to participate in a clinical study under article L. 1121-16 of the French Public Health Code.
研究组 & 干预措施
Conservative treatment group
干预措施: Immobilisation by cast boot (Procedure)
Minimally invasive surgery group
干预措施: Minimally invasive surgical application of Calcanail® (Procedure)
结局指标
主要结局
To show a significant difference in favour of minimally invasive surgical treatment compared with orthopaedic treatment for displaced articular fractures of the calcaneus.
时间窗: 1 year follow-up
The primary endpoint is the American Orthopaedic Foot \& Ankle Society (AOFAS) clinical score
次要结局
- Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the rate of early complications (skin problems, infections, complex regional pain syndrome)(1 year follow-up)
- Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the rate of late complications (rate of arthrodesis revision)(1 year follow-up)
- Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :Improved anatomical relationships (radiological measurements)(1 year follow-up)
- Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on : Improved bootability at 1 year.(1 year follow-up)
- Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the time taken to return to work and sport at 1 year.(1 year follow-up)
- Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on : An improvement in the patient self-assessment score (SAV) at 1 year.(1 year follow-up)