Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

Not Applicable

Completed

• Conditions: Tibial Fractures
• Interventions: Procedure: Infrapatellar approach; Procedure: Suprapatellar approach

• Registration Number: NCT01341418
• Lead Sponsor: Florida Orthopaedic Institute

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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Primary Completion: 2014-01
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infrapatellar approach	Infrapatellar approach	surgical approach for intramedullary nailing of the tibia
Suprapatellar approach	Suprapatellar approach	surgical approach for intramedullary nailing of the tibia

Primary Outcome Measures

Name	Time	Method
residual postoperative knee pain	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 Outcome Measures

Name	Time	Method
union/alignment of tibia	3 months postoperatively	AP and lateral radiographs will be used to evaluate union/alignment of the tibia.
knee function	6 months postoperatively	A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.
trochlear changes in the patello-femoral cartilage	1 year	Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes.

Trial Locations

Locations (2)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

St. Josephs Hospital; 🇺🇸 Tampa, Florida, United States