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

This study is ongoing, but not recruiting participants.
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: November 11, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Boston Medical Center:

Primary Outcome Measures:
  • SF-12v2 [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]
  • SMFA [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]
  • Knee Society Score [ Time Frame: Up to 24 months post op ] [ Designated as safety issue: No ]
  • Clinical Assessment [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-operation (secondary procedures) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
  • nonunion [ Time Frame: Until radiographically healed ] [ Designated as safety issue: Yes ]
  • superficial infection rates (wound only) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
  • deep infection (bone implant interface) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
  • compartment syndrome [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
  • malunion (>5 degrees varus/valgus) [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
  • >5 degrees anterior or posterior angulation [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
  • >10 malrotation degrees, and >1cm shortening) [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
  • knee range of motion [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: February 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Randomized Arm
Randomized treatment
Device: reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
Other Name: reamed, interlocking intramedullary nail
Device: locking periarticular plate
Standard of care device for femur fractures
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
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

No publications provided

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
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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 September 18, 2014