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Orthopaedic Trauma Institute Clinical Research Center

Orthopaedic Trauma Institute Clinical Research Center
2540 23rd Street, 
Bldg 7, 3rd Floor, Rm 3110 
San Francisco, CA 94110
Tigist.Belaye@ucsf.edu  

The Clinical Research Center (CRC), led by Saam Morshed, MD, MPH, PhD, is dedicated to designing and implementing clinical studies to answer the most important questions in the care of patients with musculoskeletal injuries. In collaboration with industry and other major trauma medical centers, the CRC develops innovative clinical trials to evaluate the latest technologies and innovative treatment approaches in orthopaedic trauma. In particular, we are interested in the treatment and management of lower extremity fractures, surgical site infections, and lower limb amputations.

Our professionally trained clinical research team includes specialists in clinical research methodology, grant administration, data management, and quality control that are dedicated to conducting safe and impactful clinical research. The CRC also provides training in clinical research for post-doctoral fellows, graduate students, orthopaedic residents, medical and undergraduate students.
 

Current Projects

  • DIFFIR

    Geriatric Distal Femur: Fixation versus Replacement: A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) versus Distal Femur Replacement (DFR)
    This study is designed to determine if acute DFR compared to ORIF results in improvements in knee pain and function in geriatric patients with distal femur fractures, as measured by the Oxford Knee Score (OKS)(52) up to 12 months with extended follow –up at 24 months.
     

  • SEXTANT

    Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures.
    The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.
     

  • ULTRAPRESS

    Development of a Novel Method for Non-invasive Diagnosis of Compartment Syndrome.
    To monitor a patient with suspected compartment syndrome, a clinician currently inserts a needle into the area of suspected compartment syndrome while an attached pressure-monitor records the pressure. An intra-compartment pressure of 30 mm Hg would signal compartment syndrome. Once a patient is suspected of compartment syndrome, ultrasound images of the affected and unaffected limb will be acquired for 30 seconds in each compartment. A processing algorithm will be applied to the ultrasound images. The investigators hypothesize that changes in muscle compartment pressure correlate to subtle changes in the ultrasound image.
     

  • ADAPT

    Does a Digital Mental Health Intervention Affect Symptoms of Depression, Anxiety and Post Traumatic Stress Disorder After Musculoskeletal Trauma? (ADAPT) A pilot and feasibility study.
    The primary objective is determining feasibility via study recruitment rate, retention rate and engagement, and providing preliminary clinical data for a definitive multicenter clinical trial.
     

  • PAAIN 2

    Personalized Pain Profiling in Hip and Knee Osteoarthritis Patients.
    We seek to better understand the patient's response to pain medications after orthopaedic surgeries. Specifically, we want to know if the response to pain medication can be predicted based on known pharmacodynamic and pharmacokinetic models of pain medications being administered. To answer this question, we need to collect a large data set of recorded and time-stamped pain medications and pain assessment scores (VAS) as well as physiologic data collected from the wearable device
    (Oura ring) and patient charts (vital signs, medical history, height, weight, sex, sleep patterns, social history, etc.) Data analysis will be performed at UCSFs.
     

  • SWRCT

    Social Worker Presence in Outpatient Fracture Clinics: A Batched Stepped-Wedge Cluster Randomized Trial
    Every year, many Canadians sustain a fracture that requires surgical treatment and results in a long recovery period. During this recovery period, patients may experience new or worsening mental health issues including depression, anxiety, or post-traumatic stress disorder. Additionally, patients may experience new or worsening social and financial problems, such as food and housing insecurity, due to being unable to work or take care of other daily responsibilities. Current care for fracture patients is focused on treating their physical injuries and overlooks these other challenges. To address this gap in care, the investigators propose having a social worker available in the fracture clinic to provide patients with support beyond the care of their physical injury.
     

  • PIVOT

    Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care with Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study (PIVOT-LC1-Pilot)
    The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with <10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.
     

  • TL-OF

    The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study 
    This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics/hospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging [MRI]) and traumatic fractures (low-energy trauma, confirmed by computed tomography [CT] or MRI).

     

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