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Completed

NCT Number: NCT00429663

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

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.

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Key information

Conditions

Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California - Davis, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reamed, interlocking intramedullary nail

Device

Standard of care device for femur fracture repair

locking periarticular plate

Device

Standard of care device for femur fractures

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2014
Study completion
2016
First posted
Feb 1, 2007
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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