A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
- Conditions
- Femoral Fractures
- Interventions
- Device: reamed, interlocking intramedullary nailDevice: locking periarticular plate
- Registration Number
- NCT00429663
- Lead Sponsor
- Boston Medical Center
- 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.
- Detailed Description
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IM Nails reamed, interlocking intramedullary nail Reamed, Interlocking Intramedullary Nail - Randomized treatment Plate Fixation locking periarticular plate Locking Periarticular Plate - Randomized Treatment
- Primary Outcome Measures
Name Time Method Short Musculoskeletal Functional Assessment (SMFA) Score 3 months, 6 months, 12 months 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.
EQ Index 3 months, 6 months, 12 months 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.
SMFA - Bother Index 3 months, 6 months, 12 months 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.
EQ-5D 3 months, 6 months, 12 months 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.
- Secondary Outcome Measures
Name Time Method Valgus of Over 5 Degrees 12 months Valgus is a deformity involving oblique displacement of part of a limb away from the midline.
Trial Locations
- Locations (22)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of California - Davis
🇺🇸Sacramento, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
UMass Memorial Medical Center
🇺🇸Worchester, Massachusetts, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
St. Mary's Hospital - Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
St. Louis University Hospital
🇺🇸St. Louis, Missouri, United States
New York Hospital for Joint Diseases
🇺🇸New York, New York, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Oklahoma/ Health Science
🇺🇸Oklahoma City, Oklahoma, United States
Orthopaedic Specialty Associates Fort Worth
🇺🇸Fort Worth, Texas, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Campbell Foundation
🇺🇸Memphis, Tennessee, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Barnes Hospital
🇺🇸St. Louis, Missouri, United States
Orthopaedic Associates of Michigan
🇺🇸Grand Rapids, Michigan, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States