Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Controlled Trial
NCT07761780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2026-08-12
Summary
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.
Conditions
- Tibial Shaft Fractures
Interventions
- PROCEDURE
-
Intramedullary Nailing Using Medial Parapatellar Approach
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.
- PROCEDURE
-
Intramedullary Nailing Using Transpatellar Approach
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.
Sponsors & Collaborators
-
Allama Iqbal Medical College
lead OTHER
Principal Investigators
-
Prof. Sajjad Hussain · AIMC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-08
- Primary Completion
- 2026-10-08
- Completion
- 2026-10-10
Countries
- Pakistan
Study Locations
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