Clinical Trials

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9 studies in Department of Orthopedic Surgery

  1. Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis

    Phoenix/Scottsdale, Ariz. View Summary

    Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is designed as a prospective, single arm stratified, multi-centre investigation. Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP). Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

    NCT ID:

    NCT01754363

    IRB Number:

    12-004492

    Who can I contact for additional information about this study?

  2. Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study

    Jacksonville, Fla. View Summary

    Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months

    NCT ID:

    NCT01931007

    IRB Number:

    12-004459

    Who can I contact for additional information about this study?

  3. Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System

    Rochester, Minn., Jacksonville, Fla. View Summary

    Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System

    Location:

    Rochester, Minn., Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The clinical research results for the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System will be compared to the control device Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).

    NCT ID:

    NCT01921309

    IRB Number:

    13-003563

    Who can I contact for additional information about this study?

    Rochester: Char Blanchard 507-284-1175
                        

    Jacksonville: Shari Kazmerchak 904-953-8354
                        
  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. 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.
  6. 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?

  7. Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)

    Jacksonville, Fla., Phoenix/Scottsdale, Ariz. View Summary

    Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)

    Location:

    Jacksonville, Fla., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The goal of this prospective randomized study is to evaluate the effectiveness of a drug, epsilon aminocaproic acid (EACA), in reducing the frequency of postoperative blood transfusion following primary total hip arthroplasty. In our institution, up to 40% of patients with a preoperative of 13.5 g/dl or less undergoing total hip arthroplasty will require a blood transfusion. Fibrinolytic drugs such as EACA and tranexamic acid (TA) have been shown to decrease blood loss during surgery and decrease the likelihood of blood transfusion during postoperative hospitalization.. Both drugs decrease the body's ability to break down a blood clot, thus pushing the balance of blood clot formation and breakdown towards clot formation. This mechanism can decrease the amount of blood loss during and after a surgical procedure. The haemostatic effect of EACA has been investigated in multiple studies with the majority showing a positive effect on postoperative hemoglobin levels and decreased blood transfusion rates. Though several studies exist revealing the effective and safe use of perioperative TA, a similar drug to EACA, there is a paucity of information on the use of EACA in total joint arthroplasty.

    NCT ID:

    NCT01391182

    IRB Number:

    11-001111

    Who can I contact for additional information about this study?

  8. Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair

    Phoenix/Scottsdale, Ariz. View Summary

    Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.

    NCT ID:

    NCT01450007

    IRB Number:

    11-001266

    Who can I contact for additional information about this study?


    Scottsdale: Andre Watkins 480-342-0349
                        

  9. 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