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| ID | Type | Description | Link |
|---|---|---|---|
| OTA 39 | Other Grant/Funding Number | Orthopaedic Trauma Association |
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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprapatellar approach | Active Comparator | surgical approach for intramedullary nailing of the tibia |
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| Infrapatellar approach | Active Comparator | surgical approach for intramedullary nailing of the tibia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprapatellar approach | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| union/alignment of tibia | AP and lateral radiographs will be used to evaluate union/alignment of the tibia. | 3 months postoperatively |
| knee function | A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy W Sanders, M.D. | Florida Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States | ||
| St. Josephs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20926959 | Background | 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. |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Infrapatellar approach | 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. |
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| 6 months postoperatively |
| trochlear changes in the patello-femoral cartilage | Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes. | 1 year |
| Tampa |
| Florida |
| 33607 |
| United States |