Status:
COMPLETED
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Orthopaedic Trauma Association
Conditions:
Tibial Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard o...
Detailed Description
The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia will be operatively managed by one of two strategies. The firs...
Eligibility Criteria
Inclusion
- Skeletally mature,
- Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs,
- Major fracture line not closer than 4cm from the proximal tibial articular surface
- Fracture requiring operative treatment amenable to either IM nail or plate
- Surgeon agreed to randomize patient
- Informed consent obtained
- Patient is English speaking
Exclusion
- Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface),
- Fracture of the proximal tibia with intraarticular extension requiring open reduction,
- Known metabolic bone disease
- Separate displaced tibial tubercle fragment,
- Soft tissue injuries compromising treatment method with nail,plate or both.
- Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair,
- Compartment syndrome of the leg diagnosed preoperatively,
- Pathological fractures,
- Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both,
- Symptomatic knee arthritis.
- Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures,
- Immunocompromised,
- Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired),
- Current or impending incarceration,
- Unlikely to follow-up in surgeon's estimation.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00429585
Start Date
February 1 2007
End Date
December 16 2020
Last Update
November 2 2021
Active Locations (29)
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1
University of Alabama - Burmingham
Birmingham, Alabama, United States, 35294
2
University of California at Davis
Davis, California, United States, 95616
3
University of California-San Francisco
San Francisco, California, United States, 94143
4
Tampa General Hospital
Tampa, Florida, United States, 33606