Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study (SP-Pilot)

February 13, 2017 updated by: Florida Orthopaedic Institute

Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Tampa, Florida, United States, 33607
        • St. Josephs Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Suprapatellar approach
surgical approach for intramedullary nailing of the tibia
Procedure: Suprapatellar approach
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
ACTIVE_COMPARATOR: Infrapatellar approach
surgical approach for intramedullary nailing of the tibia
Procedure: Infrapatellar approach
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
union/alignment of tibia
Time Frame: 3 months postoperatively
AP and lateral radiographs will be used to evaluate union/alignment of the tibia.
3 months postoperatively
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.
6 months postoperatively
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.
1 year

Collaborators and Investigators

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

Sponsor

Florida Orthopaedic Institute

Collaborators

Orthopaedic Trauma Association

Investigators

  • Principal Investigator: Roy W Sanders, M.D., Florida Orthopaedic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (ESTIMATE)

April 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-2676-3103
  • OTA 39 (OTHER_GRANT: Orthopaedic Trauma Association)

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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