Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures
RSA
1 other identifier
observational
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 6, 2015
May 1, 2015
3 years
May 2, 2012
May 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in inter-fragmentary motion throughout the course of healing for distal femoral fractures.
Use radiostereometric analysis to measure inter-fragmentary motion
Change in inter-fragmentary motion from baseline at 2 weeks, 6 weeks, 3 months, 6 months and 1 year postoperatively
Study Arms (1)
Distal Femur Fracture, LISS Plate
Patients 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.
Interventions
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.
Eligibility Criteria
All potential subjects will be in the inpatient setting of Massachusetts General Hospital or Brigham \& Women's Hospital at the time of recruitment awaiting surgery on their distal femur fracture
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S Vrahas, MD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Charles Bragdon, Ph.D
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Michael J Weaver, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Orthopaedic Trauma Service
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 8, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
May 6, 2015
Record last verified: 2015-05