Retrograde Nail Versus Double Plating for Distal Femoral Extra-articular and Simple Articular Fractures With Metaphyseal Comminution
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Oxford Knee Score
研究概览
简要总结
The objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution.
详细描述
Fractures of the distal femur are complex injuries that constitute a challenge to the orthopedic surgeon. It represents about 7% of all the femoral fractures. It usually occurs during high energy trauma in younger patients and frequently is associated with concomitant injuries. In elderly patients with severe osteopenia might sustain solitary distal femoral fractures from minor trauma such as simple fall.
The challenge for the surgeons remains in the balance of providing stable fixation to support physiological loading until union while allowing necessary micro motion for callus formation. So, significant advances have been made in treatment of these fractures in the past few decades. It is recognized that operative fixation with the ability to maintain anatomical reduction of the joint surface, restoring axial ligament and early range of motion presents clear advantages over closed means of treatment.
There are principles that have been proposed for the treatment of these fractures which include anatomical reduction of distal femoral articular surface, stable internal fixation, minimal soft tissue stripping and early active mobilization.
Comminuted distal femur fractures are associated with extensive soft tissue injuries like injuries to Ligaments of the knee, injuries to the surrounding muscles additional challenges like extensive bone loss, loss of soft tissue coating and these fractures produce very unfavorable conditions for fracture union. As the long list of challenges a surgeon has to face while treating such injuries, the functional outcomes are usually not satisfactory. These fractures are associated with high rates of malunion, nonunion and infection.
Intramedullary (IM) nail offers a potential biomechanical advantage over side plates and screws because the Intramedullary location results in less stress over the implant and better stress distribution than with eccentric side plate and screws. They have the potential for load shearing. Their use involves minimal soft tissue injury, short operative time, limited perioperative blood loss, and ability to mobilize patients early.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male patients aged more than 18 years old and females more than 16 years old.
- •Both genders
- •Extra-articular fracture with metaphyseal comminution
- •Simple articular fractures with metaphyseal comminution
排除标准
- •Skeletally immature patients
- •Pathological fractures
- •Open fractures
- •Periprosthetic fractures
- •Medically unfit patients
- •Patients with pre-existing knee pathology
- •Neuro-vascular ipsilateral lower limb injuries
研究组 & 干预措施
Group A: will be treated by retrograde nail
干预措施: Retrograde nail (Procedure)
Group B :will be treated by double plating
干预措施: Double plating (Procedure)
结局指标
主要结局
The Oxford Knee Score
时间窗: 6 months
The Oxford Knee Score (OKS) is a 12-item patient-reported specifically designed and developed to assess function and pain after around knee surgeries. It is short, reproducible, valid and sensitive to clinically important changes. Scores range from 0 to 48, with lower scores indicating severe arthritis (0-19) and higher scores representing better joint function (40-48).
次要结局
- Radiographic evaluation: The standard antero-anterior and the lateral radiograph views and oblique views will be evaluated both pre- and post-operatively for assessment of union and alignment and/or CT when necessary(before surgery and 6 months postoperative)
研究者
Ahmed Elsayed Abdellah Elwarwary
Resident at Orthopedic surgery Ain Shams University
Benha University
