Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures (RSA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mark Steven Vrahas, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01593176
First received: May 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Distal Femur Fractures
Procedure: Placement of RSA beads

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Use radiostereometric analysis to measure inter-fragmentary motion


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Distal Femur Fracture, LISS Plate
Patients presenting with a distal femur fracture requiring surgical fixation with a Less Invasive Stabilization System (LISS) plate.
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.
Other Names:
  • RSA Biomedical Tantulum Markers
  • Synthes Less Invasive Stabilization System Fixation Plate

Detailed Description:

Determining when a fracture has united can be very difficult. Plain radiographs are easy to obtain but are notoriously inaccurate for determining union. CT scans are more helpful, but are more costly and inconvenient. Artifacts from the metal implants often mask the visibility of the bone structure. In addition, the accuracy of CT scans for determining non-unions is not known. CT scanning will identify a nonunion when a clear persistent fracture line separates the fragments. Unfortunately, the scans often reveal some areas where bone has bridged the fracture, and other areas where the fracture line remains. Ultimately, no one knows the amount of bridging necessary to stop motion between the fragments. Often the best indication of fracture healing is the resolution of pain. However, patients' pain tolerance varies greatly. It is clear that our specialty needs better techniques to determine fracture union. This is particularly important since the market is introducing many new drugs that purport increased rate of fracture healing. If there are no standards to evaluate fracture healing, there is no way to determine drug efficacy.

Radiostereometric analysis (RSA) is a highly accurate, precise, safe and objective technique that uses radiographs to measure very small displacements and relative motion over time. It has been used successfully for some time to evaluate small changes in the position of prosthetic joints. There is some indication that this technique can also be used to evaluate healing by determining when motion between the fragments stops. A limited number of phantom model RSA in-vitro studies have proven useful for measuring the rigidity of different types of osteosyntheses methods. However, RSA has so far only been applied in a few in-vivo studies to evaluate fracture healing.

Osteosynthesis of distal femur fractures is challenging. Fractures are reduced through a large skin incision and often patients face non-union or union in a varus or valgus deformity after a long convalescence. That said, increased fracture fixation is now achievable through the newly invented locked angle screw plate system. The Synthes product, Less Invasive Stabilization System (LISS) plate is one example of this new system. The exact time of fracture healing, however, remains uncertain. No RSA in-vivo studies have been published among patients with distal femur fractures - but one RSA in-vitro study on 18 phantom distal femurs demonstrates RSA to be a relatively simple way to collect and analyze the relative motion between fragments fixed with the LISS.8 Given this, it should be possible to evaluate fragment motion in distal femur fractures stabilized using the LISS plate in order to evaluate healing.

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. Patients will be evaluated during outpatient follow-up visits standard for this fracture (2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.)

The purpose of this study is to use RSA to evaluate fracture healing in distal femoral fractures osteosynthezed using the LISS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593176

Contacts
Contact: Mark S Vrahas, MD 617-726-2943 mvrahas@partners.org
Contact: Jordan H Morgan, BS 617-643-3653 jhmorgan@partners.org

Locations
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael J Weaver, MD    617-525-8088    mjweaver@partners.org   
Principal Investigator: Michael J Weaver, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mark S Vrahas, MD    617-726-2943    mvrahas@partners.org   
Principal Investigator: Mark S Vrahas, MD         
Sub-Investigator: Charles Bragdon, Ph.D         
Sub-Investigator: Jordan H Morgan, BS         
Sub-Investigator: Meridith Greene, BS         
Sub-Investigator: Audrey Nebergall, BS         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Mark Steven Vrahas, Chief, Orthopaedic Trauma Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01593176     History of Changes
Other Study ID Numbers: 2011P001012
Study First Received: May 2, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Femur
Fracture
Radiostereometric Analysis

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014