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

This study has been terminated.
(Low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Florida Orthopaedic Institute
ClinicalTrials.gov Identifier:
NCT01553630
First received: March 8, 2012
Last updated: November 10, 2014
Last verified: November 2014
  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
Femoral Fractures
Tibial Fractures
Procedure: RIA bone graft
Procedure: Surgery without bone graft

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


Enrollment: 6
Study Start Date: May 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RIA bone graft
Surgery: open reduction and internal fixation (ORIF) of high energy metaphyseal fractures with Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.
Procedure: RIA bone graft
Acute autogenous bone grafting with RIA graft at the time of surgical fixation.
Active Comparator: Surgery without bone graft
Surgery:open reduction and internal fixation (ORIF) of high energy metaphyseal fractures without Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.
Procedure: Surgery without bone graft
Plating of fracture without bone graft

Detailed Description:

Study procedures:

Eligible fractures will be identified, consented and randomized to RIA augmentation or non graft treatment. Bone graft will be harvested through the fracture at the time of the definitive fixation procedure. No additional graft can be utilized acutely (No iliac crest bone graft, or INFUSE, OP-1, Callos, etc).

Randomization Procedures: We will be using Research Randomizer to calculate a random assignment design for Group A and Group B, which will be kept by the Research Coordinator. Once a patient agrees to participate in the study and signs an Informed Consent Form, the treating surgeon will request the treatment assignment from the Research Coordinator prior to the surgery. Group A will receive RIA augmentation. Group B will receive non-graft treatment. Patient outcomes will be analyzed using intention to treat principles.

Surgical Procedures: Locked lateral plating of comminuted supracondylar femur and distal tibia fractures is an accepted standard of care. In severely comminuted fracture patterns, restoration of length and alignment often leaves substantial fracture gap increasing the risk of fracture nonunion. Historically, this has been accepted with the plan to return to the patient to surgery for bone grafting at a later date if the nonunion is developing. Intra-focal reaming with irrigation & aspiration (RIA) at time of initial surgery allows for acute autogenous bone grafting with no increased morbidity to the patient.

Surgery for Group A receiving bone graft follows the same course as without acute grafting (same incision, dissection etc.) with the exception that after initial exposure, a guide wire is placed into the proximal femoral canal (retrograde) through the fracture, and graft is harvested using the RIA system. The RIA system has a reservoir to collect the reamings as they are aspirated from the fracture site. Reduction and fixation with locked plates then proceed as usual and the harvested graft is then placed into the residual gap with the expectation that nonunion rates may be decreased. A theoretical advantage is the renewed fracture hematoma that will collect at the fracture site secondary to reaming the canal which may also increase union rates and time to union. No increased morbidity is incurred and the increased surgical time is under 10 minutes.

  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 Jospehs Hospital
Tampa, Florida, United States, 33607
Tampa General Hospital
Tampa, Florida, United States, 33606
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: November 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Orthopaedic Institute:
Fractures
distal femur fractures
distal tibial fracures

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

ClinicalTrials.gov processed this record on November 25, 2014