Skip to main content
OpenTrials
Completed

NCT Number: NCT01341418

Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tibial Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Josephs Hospital, Tampa, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suprapatellar Approach

Procedure

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.

Other names: semi-extended approach

Infrapatellar Approach

Procedure

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.

Other names: standard tibial nailing approach

Primary outcomes

  1. residual postoperative knee pain

    Time frame: 1 year

    A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.

Secondary outcomes

  1. union/alignment of tibia

    Time frame: 3 months postoperatively

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

  2. knee function

    Time frame: 6 months postoperatively

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

  3. trochlear changes in the patello-femoral cartilage

    Time frame: 1 year

    Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes.

Sponsors and collaborators

Lead sponsor

Florida Orthopaedic Institute

Network

Collaborators

  • Orthopaedic Trauma Association

Registry information

Official study title

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

Acronym: SP-Pilot

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Apr 25, 2011
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.