RCT - Suprapatellar Approach Versus Lateral Parapatellar Approach in Tibial Shaft Fracture (ELPP)

June 14, 2026 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

Comparison of Suprapatellar Approach Versus Extra-articular Lateral Parapatellar Approach in Tibial Shaft Fractures: A Randomized Controlled Trial

This study aims to compare 2 surgical techniques for tibial shaft nailing (suprapatellar approach vs extra-articular lateral parapatellar approach). following peri-operative and postoperative outcomes

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial study, compared extra-articular lateral parapatellar approach with suprapatellar approach in tibial shaft nailing. peri-operative data are operative time, blood loss, fluoroscopy time, hospital stay. post-operative outcomes include Lysholm Knee Score, VAS-knee, range of motion. these outcomes are following postoperative day 1, 2 weeks, 6 weeks, 3 months and 6 months.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tiwat Wongkasemjit M.D., Resident
  • Phone Number: +66893146833
  • Email: toytiwat@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18-60 years
  • tibial shaft fractures

Exclusion Criteria:

  • pervious knee injury
  • open fracture at least Gustilo grade II
  • ipsilateral femur and ankle fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: suprapatellar approach
Procedure: suprapatellar approach
semi-extended position longitudinal incision 2 cm. above patella nail insertion procedure under patellofemoral joint
Experimental: extra-articular lateral parapatellar approach
Procedure: extra-articular lateral parapatellar approach
semi-extended position longitudinal incision 4-5 cm., lateral to patellar tendon nail insertion procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lysholm Knee Score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: operation
operation
VAS score of knee
Time Frame: POD 1, 2 weeks, 6 weeks, 3 months, 6 months
POD 1, 2 weeks, 6 weeks, 3 months, 6 months
range of motion
Time Frame: POD 1, 2 weeks, 6 weeks, 3 months, 6 months
knee
POD 1, 2 weeks, 6 weeks, 3 months, 6 months
intraoperative blood loss
Time Frame: operation
operation
fluoroscopy time
Time Frame: operation
operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 14, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 016/2567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data was save in form of Microsoft excel spreadsheet and SPSS file

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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