Orthopaedic Trauma Institute Clinical Research Center (CRC)
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.
For more information about our research opportunities, please contact the clinical research manager Tigist Belaye (firstname.lastname@example.org).
Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation with and without a Tibia-fibula Synostosis (Ertl) Procedure
A multi-center randomized clinical trial comparing the functional outcomes of patients undergoing a tibia-fibula synostosis (Ertl procedure) versus a standard posterior flap procedure (Burgess procedure). The primary outcome is to assess the fit and alignment of the prosthesis with the level of comfort and satisfaction of each treatment. We will also examine the rate of re-hospitalizations for complications, resource utilization, and overall treatment cost.
Sponsor: Department of Defense Congressionally Directed Medical Research Program (DoD CDMRP)
Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma (ProFit)
Principal Investigator: Saam Morshed, MD, MPH, PhD
The PROFIT trial aims to investigate prosthesis fit, alignment and conditions of the residual limb in patients currently enrolled in the Transtibial Amputation Outcome Study (TAOS). The goal of this study is to validate and refine the prosthetic assessment tool (ProFit) that was developed by an expert panel of certified prosthetist orthotists (CPOs), orthopaedic trauma investigators, a measurement scientist and a biomedical engineer from the BADER consortium.
Sponsor: Department of the Army – U.S. Army Medical Research Acquisition Activity (USAMRAA)
A Prospective Randomized Trial to Assess PO versus IV Antibiotics for the Treatment of Post-op Wound Infection after Extremity Fractures (POvIV)
A multi-center clinical trial comparing the efficacy of oral antibiotics (PO) versus intravenous (IV) antibiotics in patients that develop a post-operative deep infection after fracture fixation. The differences in rates of re-hospitalization, infection, non-union, and amputation will be assessed. We will also determine the rates of compliance and medical costs associated with each treatment.
Sponsor: Department of Defense Peer Reviewed Orthopaedic Research Program (DoD PRORP)
A Pragmatic Randomized Trial Evaluating Preoperative Aqueous Antiseptic Skin Solutions in Open Fractures (A-PREP)
A-PREP is a multi-center clinical trial comparing the effectiveness of aqueous pre-operative antiseptic skin preparation with 10% povidone-iodine versus 4% chlorhexidine gluconate (CHG) for management of open fractures. Effectiveness will be evaluated by the occurrence of surgical site infection and unplanned fracture-related reoperations.
Funders: US Department of Defense (DoD), Physician Services Incorporated, and McMaster University Surgical Associates
Hip Fracture Accelerated Surgical Treatment and Case Track (HIP ATTACK) Trial
Site Co-Investigator: Meir Marmor, MD
This international multi-center randomized clinical trial aims to determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 30-day risk of major perioperative complications in patients who have suffered a low-energy hip fracture. Total mortality and nonfatal complications will be assessed at 1 year after randomization.
Sponsor: Population Health Research Institute (PHRI)
The ‘Delta Well- Leg’ Compartment Pressure– A New Objective Measurement for the Diagnosis of Compartment Syndrome
This is a prospective cross-sectional study designed to determine whether the difference between compartment pressures in the injured and uninjured leg (‘delta well-leg’) is a reliable diagnostic tool in diagnosing compartment syndrome in acute tibia fractures. We specifically aim to validate the ‘delta well-leg’ against the current standard ‘delta P’ as a diagnostic measure and develop threshold values for the “delta well-leg”.
Funder: Orthopaedic Research Education Foundation (OREF) and AO Trauma North America Foundation (AO Foundation)
3D Printed Cast vs Synthetic Cast in Non-operative Distal Radius Fractures
Principal Investigator: Nicolas Lee, MD
This is a randomized controlled trial comparing patient satisfaction between 3D-printed casts and synthetic casts in patients with non-operative distal radius fractures. Patients randomized to the 3D group will be placed in a personalized printed cast designed by Standard Cyborg. Functional outcome will be assessed as a secondary outcome.
Funder: San Francisco Department of Public Health
Early Weight Bearing After Fixation of the Ankle Syndesmosis
Principal Investigator: Meir Marmor, MD
Co-Investigator: Saam Morshed MD, MPH, PhD
In collaboration with the Hitchcock Research Group at the Department of Bioengineering, University of Utah, we are conducting a prospective observational pilot study to evaluate the functional outcome of early-protected weight bearing after ankle syndesmosis fixation. In this study, patients will be fitted with a CAM boot along with a personalized Ambulatory Tibial Load Analysis System (ATLAS) sensor insole and will be allowed to weight bear as tolerated 2 weeks after surgery. The ATLAS device will record all weight bearing events up to 12 weeks after surgery to report the degree of patient self-modulation.
Funder: New Orthopaedic Vision Award (NOVA) Department of Orthopaedic Surgery, UCSF
Biological characterization of the cartilage fracture callus and evaluation of new therapies to treat recalcitrant fractures (Callus Study)
Principal Investigator: Ralph Marcucio, PhD
Co-Investigator: Meir Marmor, MD
This is a study analyzing the mechanism of bone regeneration in humans. The objective is to compare the process of fracture healing in humans to that of laboratory mice to gain a better understanding of the biological mechanism of endochondral ossification. We specifically aim to validate the process of hypertrophic chondrocyte to osteoblast transdifferentiation and develop new therapies to improve bone-healing outcomes based on this mechanism.
- Curtis W, Marmor M. Resection Arthroplasty Compared With Total Hip Arthroplasty in Treating Chronic Hip Pain of Patients With a History of Substance Abuse. J Arthroplasty. 2018 Aug;33(8):2560-2565. doi: 10.1016/j.arth.2018.03.016. Epub 2018 Mar 16. PubMed PMID: 29666030.
- Patterson JT, Morshed S. Chemoprophylaxis for Venous Thromboembolism in Operative Treatment of Fractures of the Tibia and Distal Bones: A Systematic Review and Meta-analysis. J Orthop Trauma. 2017 Sep;31(9):453-460. doi: 10.1097/BOT.0000000000000873. Review. PubMed PMID: 28459774.
- Cunningham BP, Brazina S, Morshed S, Miclau T 3rd. Fracture healing: A review of clinical, imaging and laboratory diagnostic options. Injury. 2017 Jun;48 Suppl 1:S69-S75. doi: 10.1016/j.injury.2017.04.020. Epub 2017 May 5. Review. PubMed PMID: 28483359.
- Mohan R, Yi PH, Morshed S. Readability of Orthopedic Trauma Patient Education Materials on the Internet. Am J Orthop (Belle Mead NJ). 2017 May/Jun;46(3):E190-E194. PubMed PMID: 28666048.
- Low EE, Inkellis E, Morshed S. Complications and revision amputation following trauma-related lower limb loss. Injury. 2017 Feb;48(2):364-370. doi: 10.1016/j.injury.2016.11.019. Epub 2016 Nov 18. PubMed PMID: 27890336.
- Baumgartner R, Libuit K, Ren D, Bakr O, Singh N, Kandemir U, Marmor MT, Morshed S. Reduction of Radiation Exposure From C-Arm Fluoroscopy During Orthopaedic Trauma Operations With Introduction of Real-Time Dosimetry. J Orthop Trauma. 2016 Feb;30(2):e53-8. doi: 10.1097/BOT.0000000000000442. PubMed PMID: 26360538.
- Morshed S, Mikhail C, Miclau Iii T. Timing of Femoral Shaft Fracture Fixation Affects Length of Hospital Stay in Patients with Multiple Injuries. Open Orthop J. 2015 Jul 31;9:324-31. doi: 10.2174/1874325001509010324. eCollection 2015. PubMed PMID: 26312117; PubMed Central PMCID: PMC4541315.
- Ghayoumi P, Kandemir U, Morshed S. Evidence based update: open versus closed reduction. Injury. 2015 Mar;46(3):467-73. doi: 10.1016/j.injury.2014.10.011. Epub 2014 Oct 14. Review. PubMed PMID: 25554424.
- Marmor M, Elson J, Mikhail C, Morshed S, Matityahu A. Short-term pelvic fracture outcomes in adolescents differ from children and adults in the National Trauma Data Bank. J Child Orthop. 2015 Feb;9(1):65-75. doi: 10.1007/s11832-015-0634-3. Epub 2015 Feb 4. PubMed PMID: 25648432; PubMed Central PMCID: PMC4340850.