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Distal Femur Fractures | Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures

Distal Femur Fractures research study

What is the primary objective of this study?

The investigators are doing this research study to look at how distal femoral fractures (knee bone break) heal. In this study, the investigators will use Radiostereometric Analysis (RSA) to look at how the pieces of femur bone move as the bone heals. RSA is a special x-ray that uses radiographs to measure very small movements in the bone over time. The question that will be answered by this study is whether RSA can be used as a tool to monitor fracture healing.

Who is eligible to participate?

Inclusion Criteria: - Male or female subjects aged 18 and older - Isolated distal femur fracture requiring surgical stabilization with a LISS plate - Subjects who are able to return to MGH for follow-up during the year following their injury. Exclusion Criteria: - Subjects with expected limited life span less than a year. - Subjects who were non ambulatory prior to their injury - Female subjects who are pregnant - Subjects who are treated with an orthopaedic implant other than the LISS - Subjects with bone structure illnesses. - Pathologic fractures secondary to neoplasm - Subject with a severe open distal femur fracture with vascular damage - Subjects who are unable to attend post-operative outpatient appointments at the MGH

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Distal Femur Fractures

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Placement of RSA beadsAt the time of surgery sets of up to 9 RSA beads will be implanted on sides of the main fractures lines with the use of the inserter instrument and the image intensifier. In AO/OTA type 33A fractures two sets will be implanted - one in the femoral shaft and one in the distal femoral epiphysis. In AO/OTA type 33C fractures with an extra fracture line through the epiphysis, three sets will be implanted - one in the femoral shaft, one in the main lateral condyle segment and one in the main medial condyle segment. No beads will be planted in comminuted bone fragments. The fracture will then be plated with a LISS plate as it normally would.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Distal Femur Fracture, LISS PlatePatients presenting with a distal femur fracture requiring surgical fixation with a Less Invasive Stabilization System (LISS) plate will have placement of RSA beads for analysis.

Study Status

Unknown status

Start Date: May 2012

Completed Date: June 2015

Phase:

Type: Observational

Design:

Primary Outcome: Change in inter-fragmentary motion throughout the course of healing for distal femoral fractures.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mark S Vrahas, MD

Lead Sponsor: Massachusetts General Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01593176

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