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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Standard of care device for tibia fracture repair; Randomized Treatment - Nail
Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Participants' Quality of Life at 3 Months
The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.
Time frame: 3 months
Participants' Quality of Life at 6 Months
The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.
Time frame: 6 months
Participants' Quality of Life at 12 Months
The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The higher the score the less quality of life problems.
Time frame: 12 months
Injury Related Limitations and Concerns at 3 Months
Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother.
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University of Alabama - Burmingham
Birmingham, Alabama, United States
University of California at Davis
Davis, California, United States
University of California-San Francisco
San Francisco, California, United States
Tampa General Hospital
Tampa, Florida, United States
Indiana University
Indianapolis, Indiana, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
...and 19 more locations
Time frame: 3 months
Injury Related Limitations and Concerns at 6 Months
Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother.
Time frame: 6 months
Injury Related Limitations and Concerns at 12 Months
Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less difficulty and bother.
Time frame: 12 month follow-up
Number of Participants With Fracture Nonunions
A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays.
Time frame: 12 months
Number of Participants With Superficial Infections
A superficial infection is an infection that occurs at the wound only. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.
Time frame: 6 months
Number of Participants With Deep Infections
A deep infection is an infection occurring at the site of the nail or plate. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.
Time frame: 6 months
Number of Participants With Compartment Syndrome
Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.
Time frame: 6 months
Number of Participants With Malunion (>5 Degrees Varus/Valgus)
Malunion is when a broken bone heals in an abnormal position. In this case, more than a 5 degree angle varus (curving into) or valgus (curving away). This is determined by a review of the participants' medical records and x-rays.
Time frame: 12 months