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

NCT ID: NCT00429585

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2020-12-16

Brief Summary

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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

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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

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Tibial Fractures

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Randomized Treatment - Nail

Randomized Treatment - Nail

Group Type OTHER

reamed, interlocking intramedullary nail

Intervention Type DEVICE

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

Randomized Treatment - Plate

Randomized Treatment - Plate

Group Type OTHER

locking periarticular plate

Intervention Type DEVICE

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

Interventions

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reamed, interlocking intramedullary nail

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

Intervention Type DEVICE

locking periarticular plate

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopaedic Trauma Association

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Tornetta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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University of Alabama - Burmingham

Birmingham, Alabama, United States

Site Status

University of California at Davis

Davis, California, United States

Site Status

University of California-San Francisco

San Francisco, California, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

St. Mary's Hospital - Mayo Clinic

Rochester, Minnesota, United States

Site Status

Barnes Hospital

St Louis, Missouri, United States

Site Status

St. Louis University Hospital

St Louis, Missouri, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

New York Hospital for Joint Diseases

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

University of Oklahoma/ Health Science

Oklahoma City, Oklahoma, United States

Site Status

Oregon health and science university

Portland, Oregon, United States

Site Status

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Campbell Foundation

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Orthopaedic Specialty Associates - Fort Worth

Fort Worth, Texas, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Victoria Hospital

London, Ontario, Canada

Site Status

St. Michaels Hospital - Toronto

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H-25923

Identifier Type: -

Identifier Source: org_study_id