Tibial Fractures
Conditions
Keywords
tibia, suprapatellar
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.
Interventions
PROCEDURESuprapatellar 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.
PROCEDUREInfrapatellar 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.
Sponsors
Orthopaedic Trauma Association
Florida Orthopaedic Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed