Tibial FracturesNCT00429585
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures
A study testing reamed, interlocking intramedullary nail and locking periarticular plate in people with Tibial Fractures, run by Boston Medical Center at 29 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- reamed, interlocking intramedullary nail and locking periarticular plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Feb 2007to 16 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 15Show fewer
- 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.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama - Burmingham
Birmingham, Alabama, 35294
Boston Medical Center
Boston, Massachusetts, 02118
Cooper University Hospital
Camden, New Jersey, 08103
Ohio State University Medical Center
Columbus, Ohio, 43210
University of California at Davis
Davis, California, 95616
Duke University Medical Center
Durham, North Carolina, 27710
Orthopaedic Specialty Associates - Fort Worth
Fort Worth, Texas, 76104
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Indiana University
Indianapolis, Indiana, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Campbell Foundation
Memphis, Tennessee, 38104
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York Hospital for Joint Diseases
New York, New York, 10003
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, 73190
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Oregon health and science university
Portland, Oregon, 97239
St. Mary's Hospital - Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester Medical Center
Rochester, New York, 14642
University of California-San Francisco
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98104
Barnes Hospital
St Louis, Missouri, 63110
St. Louis University Hospital
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Canada2 sites
Victoria Hospital
London, Ontario, N6A 4G5
St. Michaels Hospital - Toronto
Toronto, Ontario, M5C 1R6
About this study
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)
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.
Read the 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.
- Conditions
- Tibial Fractures
- Being tested
- reamed, interlocking intramedullary nail, locking periarticular plate
- Keywords
- tibia fracture, proximal tibia, interlocking intramedullary nail, locking periarticular plate, open reduction, internal fixation
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reamed, interlocking intramedullary nailDevice
Standard of care device for tibia fracture repair; Randomized Treatment - Nail
locking periarticular plateDevice
Standard of care device for tibia fracture repair; Randomized Treatment - Plate
| Study group | Role | What they receive |
|---|---|---|
| Randomized Treatment - Nail | Other | Randomized Treatment - Nail Receives: Device: reamed, interlocking intramedullary nail |
| Randomized Treatment - Plate | Other | Randomized Treatment - Plate Receives: Device: locking periarticular plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completion30 Nov 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor
- Investigators
- Paul Tornetta, M.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429585
- Sponsor's protocol ID
- H-25923
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2007
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00429585
- Acronym / sponsor ID
- H-25923
- Conditions
- Tibial Fractures
- Keywords
- tibia fracture, proximal tibia, interlocking intramedullary nail, locking periarticular plate, open reduction, internal fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Feb 2007 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Treatment - Nail | Other | Device: reamed, interlocking intramedullary nailRandomized Treatment - Nail |
| Randomized Treatment - Plate | Other | Device: locking periarticular plateRandomized Treatment - Plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reamed, interlocking intramedullary nailStandard of care device for tibia fracture repair; Randomized Treatment - Nail | Device | Randomized Treatment - Nail |
| locking periarticular plateStandard of care device for tibia fracture repair; Randomized Treatment - Plate | Device | Randomized Treatment - Plate |
Primary outcome
Participants' Quality of Life at 3 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 month follow-up
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.
5 secondary outcomes
Number of Participants With Fracture Nonunions
Time frame: 12 months
Number of Participants With Superficial Infections
Time frame: 6 months
Number of Participants With Deep Infections
Time frame: 6 months
Number of Participants With Compartment Syndrome
Time frame: 6 months
Number of Participants With Malunion (>5 Degrees Varus/Valgus)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Tornetta, M.D. principal investigator
Boston University
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reamed, interlocking intramedullary nail and locking periarticular plate in people with Tibial Fractures, run by Boston Medical Center at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' Quality of Life at 3 Months (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021; AzTrials last refreshed its copy on 29 Oct 2026.