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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00429663
First received: January 30, 2007
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Femoral Fractures Device: reamed, interlocking intramedullary nail Device: locking periarticular plate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Paul Tornetta, III, M.D., Boston Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 160
Study Start Date: February 2007
Study Completion Date: December 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IM Nails
Reamed, Interlocking Intramedullary Nail - Randomized treatment
Device: reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
Plate Fixation
Locking Periarticular Plate - Randomized Treatment
Device: locking periarticular plate
Standard of care device for femur fractures

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429663

  Show 22 Study Locations
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Paul Tornetta, M.D. Boston University
  More Information

Responsible Party: Paul Tornetta, III, M.D., Paul Tornetta,III,M.D, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00429663     History of Changes
Other Study ID Numbers: H-25934
Study First Received: January 30, 2007
Results First Received: December 18, 2016
Last Updated: April 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paul Tornetta, III, M.D., Boston Medical Center:
distal femur
femur fracture

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 18, 2017