A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Device: reamed, interlocking intramedullary nail; Device: locking periarticular plate

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • Victoria Hospital
    • Toronto, Ontario, Canada, M5C 1R6
      • St. Michaels Hospital - Toronto
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama - Burmingham
  • California
    • Davis, California, United States, 95616
      • University of California at Davis
    • San Francisco, California, United States, 94143
      • University of California-San Francisco
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Rochester, Minnesota, United States, 55902
      • St. Mary's Hospital - Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University Hospital
    • Saint Louis, Missouri, United States, 63110
      • Barnes Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • New York, New York, United States, 10003
      • New York Hospital for Joint Diseases
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma/ Health Science
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Campbell Foundation
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Orthopaedic Specialty Associates - Fort Worth
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Randomized Treatment - Nail	Device: reamed, interlocking intramedullary nail; Standard of care device for tibia fracture repair; Randomized Treatment - Nail
Other: Randomized Treatment - Plate	Device: locking periarticular plate; Standard of care device for tibia fracture repair; Randomized Treatment - Plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Orthopaedic Trauma Association
• Investigators: Principal Investigator: Paul Tornetta, M.D., Boston University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2007
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: January 30, 2007
• First Submitted That Met QC Criteria: January 30, 2007
• First Posted (Estimate): February 1, 2007

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: internal fixation; tibia fracture; open reduction; proximal tibia; interlocking intramedullary nail; locking periarticular plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: H-25923

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes