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

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01553630
• Other study ID #: Reamed Locked Plating
• Status: Terminated
• Phase: N/A
• First received: March 8, 2012
• Last updated: November 10, 2014
• Start date: May 2010
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Florida Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Tibial Fractures

Intervention

Procedure:
• RIA bone graft
Acute autogenous bone grafting with RIA graft at the time of surgical fixation.
• Surgery without bone graft
Plating of fracture without bone graft

Locations

Country	Name	City	State
United States	St Jospehs Hospital	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to union	This will be evaluated with the reading of xrays	3 months, 6 months and 1 year	No
Secondary	Reoperation rate	The rate of re operation will be evaluated	3 months, 6 months, 1 year	No