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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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)

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 Summary: 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.
Sponsor: Boston Medical Center

Current Primary Outcome:

  • EQ-5D [ Time Frame: 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.
  • Short Musculoskeletal Functional Assessment (SMFA) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome:

  • SF-12v2 (administered at the pre-op, 3, 6, 12, and 24 month visits)
  • EQ-5D (administered at the pre-op, 3, 6, 12, and 24 month visits)
  • SMFA (administered at the pre-op, 3, 6, 12, and 24 month visits)
  • Knee Society Score (completed by the physician at 3, 6, 12, and 24 month visits)
  • Clinical Assessment (completed by the physician at 2, 3, 6, 12, and 24 month visits)


Current Secondary Outcome: Valgus of Over 5 Degrees [ Time Frame: 12 months ]

Valgus is a deformity involving oblique displacement of part of a limb away from the midline.


Original Secondary Outcome:

  • Re-operation (secondary procedures)
  • nonunion
  • superficial infection rates (wound only)
  • deep infection (bone implant interface)
  • compartment syndrome
  • malunion (>5 degrees varus/valgus)
  • >5 degrees anterior or posterior angulation
  • >10 malrotation degrees, and >1cm shortening)
  • knee range of motion


Information By: Boston Medical Center

Dates:
Date Received: January 30, 2007
Date Started: February 2007
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017