NCT01341418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

April 20, 2011

Last Update Submit

February 13, 2017

Conditions

Tibial Fractures

Keywords

tibiasuprapatellar

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • union/alignment of tibia

    3 months postoperatively

  • knee function

    6 months postoperatively

  • trochlear changes in the patello-femoral cartilage

    1 year

Study Arms (2)

Suprapatellar approach

ACTIVE COMPARATOR

surgical approach for intramedullary nailing of the tibia

Procedure: Suprapatellar approach

Infrapatellar approach

ACTIVE COMPARATOR

surgical approach for intramedullary nailing of the tibia

Procedure: Infrapatellar approach

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.

Also known as: semi-extended approach
Suprapatellar approach
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.

Also known as: standard tibial nailing approach
Infrapatellar approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

St. Josephs Hospital

Tampa, Florida, 33607, United States

Location

Related Publications (1)

  • Gelbke MK, Coombs D, Powell S, DiPasquale TG. Suprapatellar versus infra-patellar intramedullary nail insertion of the tibia: a cadaveric model for comparison of patellofemoral contact pressures and forces. J Orthop Trauma. 2010 Nov;24(11):665-71. doi: 10.1097/BOT.0b013e3181f6c001.

    PMID: 20926959BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Roy W Sanders, M.D.

    Florida Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 25, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

US(2)