Clinical Trials

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8 studies in Department of Orthopedic Surgery

  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. 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
                        


  4. 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


  5. 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?

  6. 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?

  7. 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
                        


  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