MedTrace Logo

Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures

NCT01593176 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Distal Femur Fractures

Interventions

PROCEDURE

Placement of RSA beads

At 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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Mark S Vrahas, MD · Massachusetts General Hospital

  • Charles Bragdon, Ph.D · Massachusetts General Hospital

  • Michael J Weaver, MD · Brigham and Women's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593176 on ClinicalTrials.gov