Prospective Randomised Controlled Trial Evaluating the Outcomes of Open Reduction-Internal Fixation With Minimally Invasive Percutaneous Plate Osteosynthesis in Lateral Malleolus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Post operative Pain
研究概览
简要总结
The aim of this study was to compare the postoperative clinical, functional and radiological results of two different surgical methods, minimally invasive percutaneous plate osteosynthesis method and open reduction-internal fixation method, for lateral malleolus fractures in patients presenting with ankle fractures.
详细描述
The study is a prospective randomized controlled clinical trial planned to be conducted at the Republic of Turkey Ministry of Health, Giresun University Faculty of Medicine, Giresun Training and Research Hospital, Department of Orthopedics and Traumatology.
The study includes patients who will undergo surgery for lateral malleolus fractures. No additional tests will be requested outside of routine clinical, radiological, and laboratory evaluations required during surgery, hospitalization, and outpatient follow-ups.
The routine treatment protocol for patients undergoing surgery for lateral malleolus fractures in clinic is as follows:
- A detailed medical history is obtained, followed by systemic and local examinations.
- Radiological evaluations, including comparative ankle radiographs (Anterior-Posterior, Lateral, and Mortise views) and computed tomography (CT) scans, are performed.
- The affected ankle is placed in a splint. Elevation and cold application are performed. Embolism prophylaxis is administered with enoxaparin.
- Anesthesia preparation is performed. The splint is removed daily for examination, and surgery is performed once skin folds are appropriate.
- Post-surgical and outpatient follow-ups include routine ankle radiographs.
- Prophylactic antibiotics are administered preoperatively.
- Analgesics, including paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), and opioids, are administered based on the patient's pain level, provided there are no contraindications.
- After surgical site monitoring, antibiotic prophylaxis, and analgesia control, the patient is discharged.
- Postoperative follow-ups are scheduled for the 2nd week, 4th week, 6th week, 3rd month, 6th month, and 1st year.
- For the first two weeks postoperatively, dressings are performed every other day, and sutures are removed during outpatient control.
- Patients walk with bilateral crutches non-weight bearing for the first 6 weeks. If syndesmosis screws are used, they are removed with a day-case hospitalization under local anesthesia at the end of the 6th week.
- Partial weight-bearing begins after the 6th week, and the load is progressively increased weekly. Crutches are discontinued 3 months postoperatively.
- Ankle range-of-motion exercises are planned and initiated by the attending surgeon before discharge.
- During outpatient follow-ups, the ankle is re-examined, and any patient complaints are evaluated and managed with appropriate investigations and treatments.
In patients who consent to participate in the study, the following data will be collected:
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 (Participant, Outcomes Assessor)
盲法说明
Patients will be informed about both surgical techniques. Informed consent will be obtained. Accepting patients will be included in the study. Which group the patients are in will be masked. The surgical group in the follow-up will be explained.
Outcome assessors were masked. Outcome assessors are senior surgeon and radiology doctor. Scoring will be taken by the senior surgeon. Radiological measurements will be performed at different times by the radiology doctor and the senior surgeon.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being a volunteer,
- •closed distal fibular epiphysis,
- •Lateral malleolus fractures operated for Weber type B or C fractures,
- •patients with regular follow-up in outpatient clinic
排除标准
- •open fractures
- •fractures accompanied by pylon fractures,
- •fractures accompanied by talus fractures,
- •patients with a previous fracture/surgery of the same or another ankle,
- •ankles accompanied by arthrosis,
- •pathological fractures
- •multitrauma or polytrauma patients,
- •those with psychiatric or neurological diseases,
- •illiterate patients,
- •congenital or acquired deformity of the lower extremities
- •Patients who could not be reduced intraoperatively closed and who underwent open surgery
结局指标
主要结局
Post operative Pain
时间窗: Preoperatively and postoperatively 8th hour, 24th hour, 2nd week, 4th week, 3rd month, 6th month and 1st year
Patients were analysed for pain scores according to the numeric pain rating scale(NPRS) for the following periods
Patient discharge time
时间窗: Up to 12 months
Preoperative, postoperative and total hospital stay and discharge times of the patients were recorded.
次要结局
- The number and duration of fluoroscopy(Postoperative 1st day)
- Functional score(Postoperatively 3rd month, 6th month and 1st year)
研究者
Emre Kurt
Principal Investigator, Medical Doctor, Orthopaedics and Traumatology,
Giresun University