- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593176
Radiostereometric Analysis of Fracture Healing in Distal Femur Fractures (RSA)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mark S Vrahas, MD
- Phone Number: 617-726-2943
- Email: mvrahas@partners.org
Study Contact Backup
- Name: Jordan H Morgan, BS
- Phone Number: 617-643-3653
- Email: jhmorgan@partners.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Mark S Vrahas, MD
- Phone Number: 617-726-2943
- Email: 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
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham & Women's Hospital
-
Principal Investigator:
- Michael J Weaver, MD
-
Contact:
- Michael J Weaver, MD
- Phone Number: 617-525-8088
- Email: mjweaver@partners.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011P001012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Distal Femur Fractures
-
University of UtahEnrolling by invitation
-
University of FloridaRecruitingDistal Femur FractureUnited States
-
Unity Health TorontoNYU Langone Health; Rush University Medical Center; Brigham and Women's Hospital and other collaboratorsRecruiting
-
Amr Gamaleldin Mahmoud Khalil GendyaCompletedGeriatrics | Distal Femur FractureEgypt
-
41medical AGAO Innovation Translation CenterRecruitingPeriprosthetic Fractures | Intra-Articular Fractures | Distal Femur Fracture | Supracondylar FractureSwitzerland, Germany
-
Unity Health TorontoRecruitingKnee Fracture | Distal Femur Fracture | Periprosthetic Fracture Around Prosthetic Joint Implant KneeCanada
-
Major Extremity Trauma Research ConsortiumUnited States Department of DefenseCompletedPilon Fracture | Tibial Plateau Fracture | Distal Femur Fracture | Distal Tibia FractureUnited States
-
Daniel HorwitzRadius Health, Inc.Not yet recruiting
-
AO Innovation Translation CenterTerminatedDistal Femur FracturesUnited States, Switzerland, Germany, Austria
-
Unity Health TorontoRecruiting
Clinical Trials on Placement of RSA beads
-
State University of New York - Upstate Medical...WithdrawnAssess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.)United States
-
Nova Scotia Health AuthorityZimmer BiometCompletedSpinal Stenosis | Spondylolisthesis | Degenerative Lumbar Disc DiseaseCanada
-
Hospital for Special Surgery, New YorkThe Hospital for Sick Children; Boston Children's HospitalRecruitingLeg Length DiscrepancyUnited States, Canada
-
Spaarne GasthuisLeiden University Medical CenterActive, not recruitingKnee Osteoarthritis | Total Knee Arthroplasty | Total Knee ReplacementNetherlands
-
East Carolina UniversityRecruiting
-
Centre Hospitalier Universitaire de NīmesTerminated
-
University of AarhusRanders Regional HospitalNot yet recruitingUrinary Tract Infections | Cesarean Section; InfectionDenmark
-
University of AarhusRanders Regional HospitalTerminatedCatheter-Related Infections | Cesarean Section; InfectionDenmark
-
University Hospital, GhentNobel BiocareCompleted