Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tibial Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suprapatellar approach

surgical approach for intramedullary nailing of the tibia

Group Type ACTIVE_COMPARATOR

Suprapatellar approach

Intervention Type 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.

Infrapatellar approach

surgical approach for intramedullary nailing of the tibia

Group Type ACTIVE_COMPARATOR

Infrapatellar approach

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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semi-extended approach standard tibial nailing approach

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No