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

Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (S.O.L.V.E.D)

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California - Davis
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Worchester, 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
    • St. Louis, Missouri, United States, 63110
      • St. Louis University Hospital
    • St. 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
  • 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 Sciences University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Campbell Foundation
  • 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: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 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: IM Nails; Reamed, Interlocking Intramedullary Nail - Randomized treatment	Device: reamed, interlocking intramedullary nail; Standard of care device for femur fracture repair
Other: Plate Fixation; Locking Periarticular Plate - Randomized Treatment	Device: locking periarticular plate; Standard of care device for femur fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valgus of Over 5 Degrees	Valgus is a deformity involving oblique displacement of part of a limb away from the midline.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2016

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): May 11, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: femur fracture; distal femur
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: H-25934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No