Back to resultsA Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
Primary Purpose
Tibial Fractures
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
reamed, interlocking intramedullary nail
locking periarticular plate
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures focused on measuring tibia fracture, proximal tibia, interlocking intramedullary nail, locking periarticular plate, open reduction, internal fixation
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.
Sites / Locations
- University of Alabama - Burmingham
- University of California at Davis
- University of California-San Francisco
- Tampa General Hospital
- Indiana University
- IU Health Methodist Hospital
- University of Maryland Medical Center
- Boston Medical Center
- UMass Memorial Medical Center
- University of Michigan Hospital
- Orthopaedic Associates of Michigan
- Hennepin County Medical Center
- St. Mary's Hospital - Mayo Clinic
- Barnes Hospital
- St. Louis University Hospital
- Cooper University Hospital
- New York Hospital for Joint Diseases
- University of Rochester Medical Center
- Duke University Medical Center
- Ohio State University Medical Center
- University of Oklahoma/ Health Science
- Oregon health and science university
- University Of Pittsburgh
- Campbell Foundation
- Vanderbilt University Medical Center
- Orthopaedic Specialty Associates - Fort Worth
- Harborview Medical Center
- Victoria Hospital
- St. Michaels Hospital - Toronto
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Randomized Treatment - Nail
Randomized Treatment - Plate
Arm Description
Randomized Treatment - Nail
Randomized Treatment - Plate
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00429585
First Posted
January 30, 2007
Last Updated
October 4, 2021
Sponsor
Boston Medical Center
Collaborators
Orthopaedic Trauma Association
1. Study Identification
Unique Protocol Identification Number
NCT00429585
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 2007 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Orthopaedic Trauma Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
tibia fracture, proximal tibia, interlocking intramedullary nail, locking periarticular plate, open reduction, internal fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomized Treatment - Nail
Arm Type
Other
Arm Description
Randomized Treatment - Nail
Arm Title
Randomized Treatment - Plate
Arm Type
Other
Arm Description
Randomized Treatment - Plate
Intervention Type
Device
Intervention Name(s)
reamed, interlocking intramedullary nail
Intervention Description
Standard of care device for tibia fracture repair; Randomized Treatment - Nail
Intervention Type
Device
Intervention Name(s)
locking periarticular plate
Intervention Description
Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Primary Outcome Measure Information:
Title
Participants' Quality of Life at 3 Months
Description
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
Title
Participants' Quality of Life at 6 Months
Description
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
Title
Participants' Quality of Life at 12 Months
Description
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
Title
Injury Related Limitations and Concerns at 3 Months
Description
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
3 months
Title
Injury Related Limitations and Concerns at 6 Months
Description
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
Title
Injury Related Limitations and Concerns at 12 Months
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Fracture Nonunions
Description
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
Title
Number of Participants With Superficial Infections
Description
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
Title
Number of Participants With Deep Infections
Description
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
Title
Number of Participants With Compartment Syndrome
Description
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
Title
Number of Participants With Malunion (>5 Degrees Varus/Valgus)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tornetta, M.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama - Burmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California at Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
University of California-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Orthopaedic Associates of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
St. Mary's Hospital - Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Barnes Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New York Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma/ Health Science
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Oregon health and science university
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University Of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Campbell Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Orthopaedic Specialty Associates - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
St. Michaels Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
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