Recruiting

Observational StudyRadiostereometric Analysis of Fracture Healing in Distal Femur Fractures

Sponsor:

Massachusetts General Hospital

Code:

NCT01593176

Conditions

Distal Femur Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placement of RSA beads

Study Details

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.

Conditions

Distal Femur Fractures

Study ID

NCT01593176

Start date

May, 2012

Status verified date

May, 2015

Completion date

Jun, 2015

Anticipated

Primary completion date

May, 2015

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

Change in inter-fragmentary motion throughout the course of healing for distal femoral fractures. [ Time Frame: Change in inter-fragmentary motion from baseline at 2 weeks, 6 weeks, 3 months, 6 months and 1 year postoperatively ]

Central Contacts and Locations

Central contacts

Mark S Vrahas, MD

617-726-2943 mvrahas@partners.org

Jordan H Morgan, BS

617-643-3653 jhmorgan@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Mark S Vrahas, MD

617-726-2943 mvrahas@partners.org

Principal Investigator:

Mark S Vrahas, MD

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michael J Weaver, MD

617-525-8088 mjweaver@partners.org

Principal Investigator:

Michael J Weaver, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 6, 2015

Last verified

May, 2015

Keywords

Femur
Fracture
Radiostereometric Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2015-05-06.