Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.

Detailed Description
-----------------
Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.

Official Title
-----------------
Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study

Conditions
-----------------
Tibial Fractures

Intervention / Treatment
-----------------
* Procedure: Suprapatellar approach
* Procedure: Infrapatellar approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming Acute tibial fractures within 4 weeks of injury Closed or open tibial fractures after appropriate irrigation and debridement Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia Skeletally mature patient Age 18 and above. Exclusion Criteria: Tibial shaft fractures that require articular reconstruction with plates Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia Tibial plateau fractures Pilon fractures Periprosthetic fractures Non-unions Prior knee surgery History of gout or rheumatoid or osteoarthritis Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation) Spinal injury Prisoner or high likelihood of incarceration Not likely to follow-up in the estimation of surgeon Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suprapatellar approach<br>surgical approach for intramedullary nailing of the tibia | Procedure: Suprapatellar approach<br>* Suprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.<br>* Other names: semi-extended approach;|
| Active Comparator: Infrapatellar approach<br>surgical approach for intramedullary nailing of the tibia | Procedure: Infrapatellar approach<br>* The Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.<br>* Other names: standard tibial nailing approach;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual postoperative knee pain | A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| union/alignment of tibia | AP and lateral radiographs will be used to evaluate union/alignment of the tibia. | 3 months postoperatively | 
| knee function | A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements. | 6 months postoperatively | 
| trochlear changes in the patello-femoral cartilage | Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tibia, suprapatellar