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

NCT00429585 | Completed Results DMC FDA Device

• 1 other identifier: H-25923
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 29

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.

Conditions

Tibial Fractures

Keywords

tibia fracture; proximal tibia; interlocking intramedullary nail; locking periarticular plate; open reduction; internal fixation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Number of Participants With Fracture Nonunions

  12 months

• Number of Participants With Superficial Infections

  6 months

• Number of Participants With Deep Infections

  6 months

• Number of Participants With Compartment Syndrome

  6 months

• Number of Participants With Malunion (>5 Degrees Varus/Valgus)

  12 months

Study Arms (2)

Randomized Treatment - Nail

OTHER

Randomized Treatment - Nail

Device: reamed, interlocking intramedullary nail

Randomized Treatment - Plate

OTHER

Randomized Treatment - Plate

Device: locking periarticular plate

Interventions

reamed, interlocking intramedullary nail DEVICE

Standard of care device for tibia fracture repair; Randomized Treatment - Nail

Randomized Treatment - Nail

locking periarticular plate DEVICE

Standard of care device for tibia fracture repair; Randomized Treatment - Plate

Randomized Treatment - Plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (29)

University of Alabama - Burmingham

Birmingham, Alabama, 35294, United States

Location

University of California at Davis

Davis, California, 95616, United States

Location

University of California-San Francisco

San Francisco, California, 94143, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

St. Mary's Hospital - Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Barnes Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

New York Hospital for Joint Diseases

New York, New York, 10003, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma/ Health Science

Oklahoma City, Oklahoma, 73190, United States

Location

Oregon health and science university

Portland, Oregon, 97239, United States

Location

University Of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Campbell Foundation

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Orthopaedic Specialty Associates - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

St. Michaels Hospital - Toronto

Toronto, Ontario, M5C 1R6, Canada

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Results Point of Contact

• Title: Paul Tornetta, MD
• Organization: Boston Medical Center

paul.tornetta@bmc.org

617-414-6295

Study Officials

• Paul Tornetta, M.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: February 1, 2007
• Primary Completion: November 30, 2020
• Study Completion: December 16, 2020
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

US (27); CA (2)