Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Controlled Trial

NCT07761780 | Recruiting DMC

• 1 other identifier: ERB195/4/06-11-2025/AIMC/JHL
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tibial shaft fracture; Intramedullary nailing; Medial parapatellar approach; Transpatellar approach

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Functional Scale (LEFS) Score

  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

Study Arms (2)

group A Medial Parapatellar Approach

EXPERIMENTAL

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.

Procedure: Intramedullary Nailing Using Medial Parapatellar Approach

Transpatellar Approach

ACTIVE COMPARATOR

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.

Procedure: Intramedullary Nailing Using Transpatellar Approach

Interventions

Intramedullary Nailing Using Medial Parapatellar Approach PROCEDURE

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.

group A Medial Parapatellar Approach

Intramedullary Nailing Using Transpatellar Approach PROCEDURE

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.

Transpatellar Approach

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allama Iqbal Medical College: lead

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

• Prof. Sajjad Hussain

  AIMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Sajjad Hussain

CONTACT

0333 4077389; prof.sajjadhussain@aimc.edu.pk

Montiha Azeem

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 12, 2026
• Study Start: August 8, 2026
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

PA (1)