Clinical trial NCT01341418: Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study
Official title: Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Keywords: tibia
suprapatellar
Lead sponsor: Florida Orthopaedic Institute
Sponsor class: NETWORK
Collaborators: name: Orthopaedic Trauma Association
First posted: 2011-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: residual postoperative knee pain
timeFrame: 1 year
Secondary outcomes:
measure: union/alignment of tibia
timeFrame: 3 months postoperatively
measure: knee function
timeFrame: 6 months postoperatively
measure: trochlear changes in the patello-femoral cartilage
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: St. Josephs Hospital
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Roy W Sanders, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.