Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in Knee Society Score
研究概览
简要总结
The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.
详细描述
Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.
The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.
There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.
Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.
In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AO 33 A3 and 33 C fractures
- •Age group ≥ 60 years
- •Closed fractures
- •Neurovascular intact
排除标准
- •Open fractures
- •Non ambulant patients
- •Patients with peripheral neurovascular diseases
- •Peri-prosthetic fractures
- •Associated other orthopedic injuries
- •Poly-traumatized patients
- •Pathological fractures
结局指标
主要结局
change in Knee Society Score
时间窗: 1 month, 6 month and 12 month
the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.
次要结局
- Postoperative complications(form first day to 12 month)
- Operative time(At the operation)
- Reoperation rate(form first day to 12 month)
- change in Knee range of motion(1 month and 12 month)
研究者
Amr Gamaleldin Mahmoud Khalil Gendya
Assistant Lecturer , Ain Shams University.
Ain Shams University
