A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

NCT00429663 | Completed Results DMC

• 1 other identifier: H-25934
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 22

Brief Summary

This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur 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

Femoral Fractures

Keywords

distal femur; femur fracture

Outcome Measures

Primary Outcomes (4)

• EQ-5D

  EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.

  3 months, 6 months, 12 months

• Short Musculoskeletal Functional Assessment (SMFA) Score

  The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.

  3 months, 6 months, 12 months

• EQ Index

  EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.

  3 months, 6 months, 12 months

• SMFA - Bother Index

  The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.

  3 months, 6 months, 12 months

Secondary Outcomes (1)

• Valgus of Over 5 Degrees

  12 months

Study Arms (2)

IM Nails

OTHER

Reamed, Interlocking Intramedullary Nail - Randomized treatment

Device: reamed, interlocking intramedullary nail

Plate Fixation

OTHER

Locking Periarticular Plate - Randomized Treatment

Device: locking periarticular plate

Interventions

reamed, interlocking intramedullary nail DEVICE

Standard of care device for femur fracture repair

IM Nails

locking periarticular plate DEVICE

Standard of care device for femur fractures

Plate Fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Skeletally mature
• Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
• Fracture requiring operative treatment amenable to either IM nail or plate
• Informed consent obtained
• Patient is English speaking

You may not qualify if:

• Fracture of the metaphyseal distal femur with intra-articular communition,
• Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
• Pathological fracture,
• Known metabolic bone disease,
• Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
• Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
• Symptomatic knee arthritis
• Soft tissue injuries compromising either treatment method with nail or plate
• 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

Study Sites (22)

University of California - Davis

Sacramento, California, 95817, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Indiana University

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

Worchester, 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

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 Sciences University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Campbell Foundation

Memphis, Tennessee, 38104, United States

Location

Orthopaedic Specialty Associates Fort Worth

Fort Worth, Texas, 76104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Results Point of Contact

• Title: Paul Tornetta III, 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: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paul Tornetta,III,M.D

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: May 11, 2017
• Results First Posted: February 9, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)