Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Lower Extremity Functional Scale (LEFS) Score
研究概览
简要总结
Tibial shaft fractures are breaks in the main part of the shin bone and commonly require surgery to restore alignment and allow the patient to return to normal activities. Intramedullary nailing is a commonly used surgical treatment for these fractures. There are different surgical approaches that can be used to insert the nail, including the medial parapatellar approach and the transpatellar approach.
This study will compare these two surgical approaches to determine whether one is associated with better recovery after surgery. A total of 56 adults with acute tibial shaft fractures will participate in the study. Participants will be randomly assigned to receive intramedullary nailing through either the medial parapatellar approach or the transpatellar approach.
Recovery will be evaluated after surgery using measures of lower-limb function, pain, and knee movement. Lower-limb function will be assessed using the Lower Extremity Functional Scale (LEFS), pain will be assessed using the Numeric Pain Rating Scale (NPRS), and knee range of motion will be measured using a universal goniometer.
Participants will be assessed at 4 weeks and 8 weeks after surgery. The main outcome of the study will be functional recovery measured by the LEFS. The study will also compare postoperative pain and knee range of motion between the two surgical approaches.
The purpose of this study is to determine whether the medial parapatellar or transpatellar approach is associated with better early functional recovery following intramedullary nailing of tibial shaft fractures. The results may help orthopedic surgeons select the surgical approach that provides better postoperative recovery for patients with tibial shaft fractures.
详细描述
Tibial shaft fractures are common long-bone injuries that frequently require operative fixation, particularly when the fracture is displaced or associated with significant soft-tissue injury. Intramedullary interlocking nailing is widely used because it provides stable fixation while allowing early mobilization and weight-bearing.
The surgical approach used to access the proximal tibia for intramedullary nail insertion may influence postoperative knee symptoms and functional recovery. The medial parapatellar and transpatellar approaches are commonly used techniques; however, previous comparative studies have reported inconsistent findings regarding postoperative pain, knee function, and range of motion.
This randomized controlled trial will compare functional recovery following intramedullary nailing of tibial shaft fractures using the medial parapatellar approach versus the transpatellar approach. Eligible participants will be randomly allocated in a 1:1 ratio to one of the two surgical approach groups.
Participants will undergo static interlocked intramedullary nailing performed by experienced orthopedic surgeons according to standardized operative and postoperative protocols. The surgical approach will be the primary difference between the two intervention groups.
The primary outcome will be functional recovery assessed using the Lower Extremity Functional Scale (LEFS). Secondary outcomes will include postoperative pain assessed using the Numeric Pain Rating Scale (NPRS) and knee range of motion assessed using a universal goniometer. Outcome assessments will be performed at 4 and 8 weeks after 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
- Single (Outcomes Assessor)
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
- •Adults aged 18 to 60 years, irrespective of sex.
- •Patients with an acute tibial shaft fracture confirmed by radiographic examination.
- •Gustilo-Anderson type I, II, or IIIA open fractures.
- •Patients who are eligible for intramedullary interlocking nailing according to the treating orthopedic surgeon.
- •Patients willing and able to provide written informed consent.
排除标准
- •Previous fracture or surgery involving the affected tibia.
- •Osteoporosis or other conditions significantly affecting bone healing.
- •Diabetes mellitus, peripheral vascular disease, autoimmune disorders, or other systemic conditions that may adversely affect bone healing or postoperative recovery.
- •Neurovascular injury involving the affected limb.
研究组 & 干预措施
group A Medial Parapatellar Approach
Participants allocated to this arm will undergo intramedullary interlocking nailing of the tibial shaft fracture using the medial parapatellar surgical approach for access to the tibial entry point. The procedure will be performed by experienced orthopedic surgeons according to the standardized operative and postoperative protocols of the study. Participants will receive routine postoperative care and rehabilitation according to the study protocol. Functional recovery, postoperative pain, and knee range of motion will be assessed at 4 and 8 weeks after surgery.
干预措施: Intramedullary Nailing Using Medial Parapatellar Approach (Procedure)
Transpatellar Approach
Participants allocated to this arm will undergo intramedullary interlocking nailing of the tibial shaft fracture using the transpatellar surgical approach for access to the tibial entry point. The procedure will be performed by experienced orthopedic surgeons according to the standardized operative and postoperative protocols of the study. Participants will receive routine postoperative care and rehabilitation according to the study protocol. Functional recovery, postoperative pain, and knee range of motion will be assessed at 4 and 8 weeks after surgery.
干预措施: Intramedullary Nailing Using Transpatellar Approach (Procedure)
结局指标
主要结局
Lower Extremity Functional Scale (LEFS) Score
时间窗: 4 and 8 weeks after surgery
Functional recovery of the affected lower extremity will be assessed using the Lower Extremity Functional Scale (LEFS), a 20-item patient-reported outcome measure evaluating difficulty with physical activities and daily functional tasks. Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better lower-extremity function. LEFS will be assessed at 4 and 8 weeks after surgery to compare functional recovery between the medial parapatellar and transpatellar approach groups.
次要结局
未报告次要终点
研究者
Prof. Sajjad Hussain Goraya
Principal Investigator
Allama Iqbal Medical College