Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Florida Orthopaedic Institute
Sponsor:
Information provided by (Responsible Party):
Florida Orthopaedic Institute
ClinicalTrials.gov Identifier:
NCT01553630
First received: March 8, 2012
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved.

Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures


Condition Intervention
Metaphyseal Fractures of the Distal Femur and Tibia
Procedure: reamed irrigator Aspirator (RIA) bonegraft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia

Resource links provided by NLM:


Further study details as provided by Florida Orthopaedic Institute:

Primary Outcome Measures:
  • Time to union [ Time Frame: 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
    This will be evaluated with the reading of xrays


Secondary Outcome Measures:
  • Reoperation rate [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
    The rate of re operation will be evaluated


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reamed Irrigator Aspirator (RIA) bone graft
open reduction and internal fixation (ORIF) of high energy metaphyseal fractures with Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.
Procedure: reamed irrigator Aspirator (RIA) bonegraft
Acute autogenous bone grafting at the time if fsurgical fixation.
No Intervention: without Reamed Irrigator Aspirator (RIA) bone graft
open reduction and internal fixation (ORIF) of high energy metaphyseal fractures without Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High energy metaphyseal fracture (distal femur or tibia) indicated for plate fixation (open or closed)
  • Adult, acute fractures only

Exclusion Criteria:

  • Unable to ream fractured bone
  • Subject is unable, unwilling or unlikely to follow up
  • Subject is under age 18 years
  • Prisoners
  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: NCT01553630

Locations
United States, Florida
St Jospephs Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Barbara Steverson, RN, MPH    813-253-2068 ext 6891    bsteverson@floridaortho.com   
Contact: Mary E Miller, RN.BSN    813-253-2068 ext 6895    mmiller@floridaortho.com   
Principal Investigator: David Watson, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Barbara Steverson, RN. MPH    813-253-2068 ext 6891    bsteverson@floridaortho.com   
Contact: Mary Miller, RN. BSN    813 253 2068 ext 6895    mmiller@floridaortho.com   
Principal Investigator: David Watson, MD         
Sponsors and Collaborators
Florida Orthopaedic Institute
  More Information

No publications provided

Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT01553630     History of Changes
Other Study ID Numbers: Reamed Locked Plating
Study First Received: March 8, 2012
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Orthopaedic Institute:
Fractures
Distal Femur and Tibia

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014