Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures

Status unconfirmed

Conditions studied: Distal Femur Fractures

In brief

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.

Key facts

Study ID

NCT01593176

Run by

Massachusetts General Hospital

People needed

30

Starts

2012-05-01

Expected to finish

2015-06-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham & Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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