Clinical Trials

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10 studies in Department of Orthopedic Surgery in Rochester, MN.

  1. A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)
    Rochester, Minn. View Summary

    A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches. The specific aim of this 21-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.

    NCT ID:

    NCT01589692

    Who can I contact for additional information about this study?

    Rochester: Tyson Scarbeck 507-538-1016
                        


  2. Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)
    Rochester, Minn. View Summary

    Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

    NCT ID:

    NCT00429585

    Who can I contact for additional information about this study?

  3. Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
    Rochester, Minn. View Summary

    Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Previous studies have reported activation of the body's immune system during the perioperative period.1  Typically, this "stress response" is limited and goes unnoticed by the patient and health care team.  However, physiologic insults that occur during major surgery may elicit a more pronounced response known as the systemic inflammatory response syndrome (SIRS).  Such a response is of great clinical consequence, as it is known to significantly worsen perioperative morbidity and mortality.1  HMG Co-A Reductase Inhibitors (hereafter identified by the common name, "the statins") are potent inhibitors of cholesterol synthesis, and their role in the treatment of atherosclerosis and prevention of coronary artery disease is well documented.2-5  Interestingly, data from animal studies have shown that statins have unique anti-inflammatory properties that are independent of their lipid lowering effects.6  Recently, statin therapy has been associated with a reduced incidence of perioperative cardiovascular and neurologic complications in major vascular and thoracic surgery patients as well as improved outcomes in patients experiencing acute coronary syndrome (ACS).7-13  In all ACS patient populations studied, improvement in outcome has been attributed to coronary plaque stabilization, presumably a result of statins mitigating the local inflammatory response at the level of the coronary plaque.

         The purpose of this study is to quantify the magnitude of perioperative inflammation during major orthopedic spine surgery and determine whether statins alter this systemic physiologic response.

    NCT ID:

    NCT00656292

    IRB Number:

    06-002881

    Who can I contact for additional information about this study?

    Rochester: Michael J. Brown, M.D. 507-284-2511
                                             
             
             
           
  4. Wound EMR to Decrease Limb Amputations in Persons With Diabetes
    Rochester, Minn. View Summary

    Wound EMR to Decrease Limb Amputations in Persons With Diabetes

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The Online Wound Electronic Medical Record (OWEMR) is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians. Use of the OWEMR includes digital photography as an objective measurement of wound healing rates.

    NCT ID:

    NCT01371318

    Who can I contact for additional information about this study?

    Rochester: Tyson Scraybeck, MD
                        


  5. Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial
    Rochester, Minn. View Summary

    Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

    NCT ID:

    NCT01714336

    IRB Number:

    12-004599

    Who can I contact for additional information about this study?

    Rochester: Chad D. Watts, M.D. 507-284-2511
                        Mark W. Pagnano, M.D. 507-284-2511


  6. Mayo Clinic Sports Medicine Program and USA Hockey have recently developed a Catastrophic Injury Registry for Ice Hockey. Our goal is to capture information on all catastrophic and potentially catastrophic injuries at all levels of ice hockey so that we can follow-up with the injured parties, and appropriately catalogue their injury experience for USA Hockey.
    Rochester, Minn. View Summary

    Mayo Clinic Sports Medicine Program and USA Hockey have recently developed a Catastrophic Injury Registry for Ice Hockey. Our goal is to capture information on all catastrophic and potentially catastrophic injuries at all levels of ice hockey so that we can follow-up with the injured parties, and appropriately catalogue their injury experience for USA Hockey.

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this USA Hockey registry is to collect information on the prevalence of catastrophic injuries for both genders in youth, high school, junior, college, national program, adult amateur, minor league, and professional ice hockey in the United States. The goal is to design and maintain a comprehensive registry of catastrophic injuries in ice hockey that will be the primary source of catastrophic ice hockey injury data in the United States. The registry will provide data to support potential rule and equipment changes.

    IRB Number:

    08-002859

    Who can I contact for additional information about this study?

    We have created an injury reporting phone line where a staff member can be contacted at 1-866-926-2563. We have also established a reporting email address at hockeyinjury@mayo.edu.
  7. A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
    Rochester, Minn. View Summary

    A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.

    NCT ID:

    NCT01066702

    IRB Number:

    12-008922

    Who can I contact for additional information about this study?

  8. A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
    Rochester, Minn. View Summary

    A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.

    NCT ID:

    NCT02049892

    Who can I contact for additional information about this study?

    Rochester: Robert T. Trousdale, M.D. 507-284-2511
                        


  9. Minimize Implants Maximize Outcomes (MIMO) Clinical Trial
    Rochester, Minn. View Summary

    Minimize Implants Maximize Outcomes (MIMO) Clinical Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The MIMO Study Group proposes to conduct a prospective randomized controlled trial in order to determine whether a low implant density cohort has equivalent clinical and radiographic results to a high implant density cohort. This study is proposed as a trial of equivalence. The null hypothesis is that significant differences exist in percent major Cobb angle correction between high- and low-implant density cohorts for Lenke 1A curve types, the most common scoliotic curve pattern (73). Consecutive qualifying patients will be screened and enrolled by high-volume spine surgeons at 14 sites and randomized to spinal instrumentation with a low- or high-density screw pattern. Patients will return at 3-months, 1-year, and 2-years for exam, radiographs, and collection of patient-reported outcome scores. The Harms Study Group Foundation will serve as a collaborating organization and will provide database development and management, secure online data collection, centralized radiographic measurements, and data quality control. The University of Minnesota team will lead study design, protocol development, IRB/data use agreement contracts, patient randomization, and statistical analysis, including quarterly data review. Imaging will be obtained either with an EOS system or using a calibration belt during the radiographs, which allows for subsequent with the 3D modeling of the deformity. Six enrolling sites currently have this capability (EOS - Montreal, St. Louis, Iowa, Mayo, DuPont, and San Diego). An additional five sites already have calibration belts - Dallas, New York, Baltimore, Boston, U. of Rochester), and new calibration belts will be fabricated for the additional sites. The Montreal site will supervise collection of radiographic data with 3D capability and assist with troubleshooting and radiographic quality control. Although the study is primarily powered to detect change in percent correction of the major coronal curve, preliminary data will be gathered on axial and sagittal plane correction as well as complications, surgical factors, and patient-reported outcomes.

    NCT ID:

    NCT01792609

    Who can I contact for additional information about this study?

    Rochester: Noelle A Larson, MD 507-244-0093
                        


  10. Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.

    NCT ID:

    NCT00984672

    IRB Number:

    08-008802

    Who can I contact for additional information about this study?

    Rochester: Vickie M. Treder, LPN 507-538-3561
                        


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