Clinical trial NCT00429585: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
Official title: Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Keywords: tibia fracture
proximal tibia
interlocking intramedullary nail
locking periarticular plate
open reduction
internal fixation
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2007-02-01
Enrollment: 108
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 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 of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

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 first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Participants' Quality of Life at 3 Months
timeFrame: 3 months
measure: Participants' Quality of Life at 6 Months
timeFrame: 6 months
measure: Participants' Quality of Life at 12 Months
timeFrame: 12 months
measure: Injury Related Limitations and Concerns at 3 Months
timeFrame: 3 months
measure: Injury Related Limitations and Concerns at 6 Months
timeFrame: 6 months
measure: Injury Related Limitations and Concerns at 12 Months
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Number of Participants With Fracture Nonunions
timeFrame: 12 months
measure: Number of Participants With Superficial Infections
timeFrame: 6 months
measure: Number of Participants With Deep Infections
timeFrame: 6 months
measure: Number of Participants With Compartment Syndrome
timeFrame: 6 months
measure: Number of Participants With Malunion (>5 Degrees Varus/Valgus)
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Burmingham
state: Alabama
city: Davis
country: United States
facility: University of California at Davis
state: California
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Rochester
country: United States
facility: St. Mary's Hospital - Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: New York Hospital for Joint Diseases
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma/ Health Science
state: Oklahoma
city: Portland
country: United States
facility: Oregon health and science university
state: Oregon
city: Pittsburgh
country: United States
facility: University Of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: Campbell Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Orthopaedic Specialty Associates - Fort Worth
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michaels Hospital - Toronto
state: Ontario
Study officials:
affiliation: Boston University
name: Paul Tornetta, M.D.
role: PRINCIPAL_INVESTIGATOR
References: