Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

Florida Orthopaedic Institute40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tibial Fractures

Interventions

Suprapatellar approachPROCEDURE

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.

Infrapatellar approachPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Tampa General Hospital

Tampa, Florida, United States

St. Josephs Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

union/alignment of tibia

AP and lateral radiographs will be used to evaluate union/alignment of the tibia.

Time frame: 3 months postoperatively

knee function

A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.

Time frame: 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.

Time frame: 1 year

Data from ClinicalTrials.gov

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