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Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures (MAPTIN)

2026年8月13日 更新者:Prof. Sajjad Hussain Goraya、Allama Iqbal Medical College

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.

研究概览

详细说明

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.

Baseline demographic and clinical characteristics, including age, sex, body mass index, time from injury to surgery, and Gustilo-Anderson fracture classification, will also be recorded.

The study will include 56 participants, with 28 participants allocated to each treatment group. Participants will be adults aged 18 to 60 years with acute tibial shaft fractures meeting the predefined eligibility criteria.

The study will evaluate whether the choice of surgical approach is associated with differences in early postoperative functional recovery, pain, and knee mobility. The findings may provide comparative evidence to support surgical decision-making and postoperative rehabilitation following intramedullary nailing of tibial shaft fractures.

研究类型

介入性

注册 (估计的)

56

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Montiha Azeem

学习地点

    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、54000
        • 招聘中
        • Jinnah Hospital Lahore
        • 接触:
        • 接触:
          • Montiha Azeem
          • 电话号码:03479717317
        • 首席研究员:
          • Prof. Sajjad Hussain

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
Intramedullary interlocking nailing of an acute tibial shaft fracture using the medial parapatellar approach for access to the proximal tibial entry point. The procedure will be performed by experienced orthopedic surgeons using standardized operative and postoperative protocols. Participants will receive routine postoperative care and rehabilitation. The intervention will be evaluated for postoperative functional recovery, pain, and knee range of motion at 4 and 8 weeks after surgery.
有源比较器: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.
Intramedullary interlocking nailing of an acute tibial shaft fracture using the transpatellar approach for access to the proximal tibial entry point. The procedure will be performed by experienced orthopedic surgeons using standardized operative and postoperative protocols. Participants will receive routine postoperative care and rehabilitation. The intervention will be evaluated for postoperative functional recovery, pain, and knee range of motion at 4 and 8 weeks after surgery.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Lower Extremity Functional Scale (LEFS) Score
大体时间: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.
4 and 8 weeks after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Prof. Sajjad Hussain、AIMC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月8日

初级完成 (估计的)

2026年10月8日

研究完成 (估计的)

2026年10月10日

研究注册日期

首次提交

2026年8月8日

首先提交符合 QC 标准的

2026年8月8日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • ERB195/4/06-11-2025/AIMC/JHL

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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