The Orthopaedic Trauma Institute Clinical Research Center
Zuckerberg San Francisco General Hospital (ZSFGH)

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 information about our Clinical Research Internship program click here link.

For more information please contact the clinical research manager Tigist Belaye, MPA, CCRP (tigist.belaye@ucsf.edu).

Current Projects:

Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation with and without a Tibia-fibula Synostosis (Ertl) Procedure

Site Co-Investigators: Theodore Miclau, MD and Saam Morshed MD, MPH, PhD

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)

Site Co-Investigators: Theodore Miclau, MD and Saam Morshed MD, MPH, PhD

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. This 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)

Site Co-Investigators: Saam Morshed MD, MPH, PhD and Theodore Miclau, MD

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

PREPARE: A Pragmatic Randomized trial Evaluating Pre-operative Alcohol skin solutions in FRactured Extremities

Site Co-Investigators: Meir Marmor, MD and Saam Morshed MD, MPH, PhD

The overarching objective of thismulticenter trial is to compare the effectiveness of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol versus 2% chlorhexidine gluconate (CHG) in 70% isopropyl alcohol for the management of extremity fractures that require surgical treatment. The primary outcome for comparison is surgical site infection (SSI), and the secondary outcome is unplanned fracture-related reoperation

Funders: US Department of Defense (DoD), Physician Services Incorporated, and McMaster University Surgical Associates

A Safety and Technical Feasibility Evaluation of the Curvafix® Intramedullary RodscrEw System for FixaTion Of Pelvic and AcetabulaR FracturEs – RESTORE Study

Principal Investigator: Amir Matityahu, MD

Sponsor: Curvafix Inc.

Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT using the Anti-Gravity Treadmill (AlterG)

Principal Investigator: Saam Morshed MD, MPH, PhD

Sponsor:  Department of Defense Peer Reviewed Orthopedic Research Program (DOD PRORP)

Sample Publications:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.