Multicenter Trials in Hip and Knee Surgery
UCSF’s Arthroplasty group, within the Department of Orthopaedic Surgery, participates in multicenter trials with academic institutions and industries across the country. These trials align with our Department’s goals of advancing the knowledge and understanding of topics that influence the effectiveness of orthopaedic surgery practices and improve patient outcomes. A core focus of this research is preventing and treating periprosthetic joint infections.
For more information about our research opportunities, please contact the clinical research coordinator, Michael Henne (ArthroplastyResearch@ucsf.edu).
Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A prospective, randomized, open-label, controlled multi-center trial
Site Co-Investigators: Thomas Vail, MD, Erik Hansen, MD, Stefano Bini, MD, Derek Ward, MD, and Thomas Barber, MD
Despite advances in surgical care and implant technology, periprosthetic joint infections (PJI and surgical site infection (SSI) after total knee arthroplasty (TKA) represents a catastrophic complication. Administration of prophylactic antibiotics before surgery is a well-established strategy to prevent PJI and SSI. However, controversy exists regarding the choice of the antibiotic, duration of prophylaxis, optimal timing, and mode of delivery of routine antibiotic prophylaxis. Level I data with regard to prophylactic antibiotics in elective TKA is limited and identifying the correct antibiotic prophylaxis protocol can have profound and wide-reaching impact. The purpose of this study is to identify the comparative effectiveness of various perioperative strategies for antibiotic delivery as prophylaxis for PJI and SSI in elective primary TKA.
Sponsor: Duke University
The Utility of Next-Generation Sequencing for the Diagnosis of Periprosthetic Joint Infection
Site Co-Investigators: Erik Hansen, MD, Stefano Bini, MD, Derek Ward, MD, and Thomas Barber, MD
The diagnosis of periprosthetic joint infection (PJI) continues to be a source of great concern for orthopaedic surgeons, and the relatively high rate of negative cultures serves to highlight the magnitude of this issue. Next-generation sequencing (NGS) is a well-established technique for amplification and sequencing of DNA material and has recently gained much attention in other fields of medicine. The aim of this study is to evaluate the ability of NGS in identifying the causative organism(s) in patients with PJI.
Sponsor: Thomas Jefferson University
External Validation of a Prognostic Calculator for the Surgical Treatment of Periprosthetic Joint Infection
Site Investigator: Erik Hansen, MD
This study investigates the use of a prognostic calculator for prosthetic joint infection that is individually tailored to the patient based on their present comorbidities, type of surgical procedure, cultured organism profile, laboratory markers, among other factors. The calculator is based on 1,438 PJIs from two institutions. By identifying the factors that influence the treatment of PJI, the physician would be able to individually assess and optimize the general medical condition of the patient. A mobile application with this risk calculator has been produced and the aim of this study is to externally validate the calculator at multiple centers around the country.
Sponsor: Indiana University
One Stage versus Two Stage For Periprosthetic Hip and Knee Infection
Site Co-Investigators: Erik Hansen, MD, Stefano Bini, MD, Derek Ward, MD, Thomas Barber, MD, Jeff Barry, MD
The purpose of this clinical trial is to investigate the outcome of one-stage and two-stage exchange arthroplasty for the management of patients with chronic PJI. The hypothesis of this non-inferiority study is that one-stage exchange arthroplasty, if performed in the appropriate patient population, carries a similar success rate for the treatment of chronic PJI as two-stage exchange arthroplasty and avoids many of the problems associated with two-stage exchange arthroplasty.
Sponsor: OrthoCarolina Research Institute
The OMEGA-SPM-DOSE: Specialized Pro-Resolving Mediators in Patients with Peripheral Artery Disease
Site Co-Investigators: Erik Hansen, MD and Michael Conte, MD
High dose n-3 polyunsaturated fatty acids (PUFAs) have been shown to play a role in the resolution of inflammation via the downstream production of specialized pro-resolving lipid mediators (SPM). The OMEGA-SPM-DOSE trials, Phase 1a and Bridging phase are two parts of a two part phase one study which aims to investigate the effect of a novel formulation of a nutritional supplement containing highly concentrated n-3 PUFA metabolites (SPM Supplement: a concentrated Solutech prep with the monohydroxylated precursors; Metagenics) on the metabolo-lipidomic profile of healthy volunteers and patients with PAD and OA.
Sponsor: Metagenics, Inc.
How to Improve the Results of Irrigation and Debridement for PJI through the use of Intraosseious Antibiotics
Site Co-Investigators: Jeff Barry, MD, Erik Hansen, MD, and Derek Ward, MD
In order to improve upon the modest results seen in irrigation and debridement for periprosthetic infection and limit the number of surgical procedures performed, we ask if the use of intraosseous regional administration of antibiotics at the time of irrigation and debridement would further improve the results of irrigation debridement for prosthetic joint infection
Sponsor: OrthoCarolina Research Institute
- Bini SA, Chan PH, Inacio MC, Paxton EW, Khatod M. Antibiotic cement was associated with half the risk of re-revision in 1,154 aseptic revision total knee arthroplasties. Acta Orthop. 2016 Feb; 87(1):55-9. PMID: 26472086
- Frank JM, Kayupov E, Moric M, Segreti J, Hansen E, Hartman C, Okroj K, Belden K, Roslund B, Silibovsky R, Parvizi J, Della Valle CJ. The Mark Coventry, MD, Award: Oral Antibiotics Reduce Reinfection After Two-Stage Exchange: A Multicenter, Randomized Controlled Trial. Clin Orthop Relat Res. 2017 Jan; 475(1):56-61. PMID: 27387759
- Hansen EN, Adeli B, Kenyon R, Parvizi J. Routine use of antibiotic laden bone cement for primary total knee arthroplasty: impact on infecting microbial patterns and resistance profiles. J Arthroplasty. 2014 Jun; 29(6):1123-7. PMID: 24418770
- Alijanipour P, Adeli B, Hansen EN, Chen AF, Parvizi J. Intraoperative Purulence Is Not Reliable for Diagnosing Periprosthetic Joint Infection. J Arthroplasty. 2015 Aug; 30(8):1403-6. PMID: 25817184
- Hansen EN, Zmistowski B, Parvizi J. Periprosthetic joint infection: what is on the horizon? Int J Artif Organs. 2012 Oct; 35(10):935-50. PMID: 23371923
- Odum SM, Fehring TK, Lombardi AV, Zmistowski BM, Brown NM, Luna JT, Fehring KA, Hansen EN. Irrigation and debridement for periprosthetic infections: does the organism matter? J Arthroplasty. 2011 Sep; 26(6 Suppl):114-8. PMID: 21621955
- Parvizi J, Pawasarat IM, Azzam KA, Joshi A, Hansen EN, Bozic KJ. Periprosthetic joint infection: the economic impact of methicillin-resistant infections. J Arthroplasty. 2010 Sep; 25(6 Suppl):103-7. PMID: 20570103
- Liu C, Kakis A, Nichols A, Ries MD, Vail TP, Bozic KJ. Targeted use of vancomycin as perioperative prophylaxis reduces periprosthetic joint infection in revision TKA. Clin Orthop Relat Res. 2014 Jan; 472(1):227-31. PMID: 23645338
- Lockhart PB, Garvin KL, Osmon DR, Hewlett AL, Scuderi G, Lewallen D, Vail T. The antibiotic prophylaxis guideline for prosthetic joints: trying to do the right thing. J Am Acad Orthop Surg. 2013 Mar; 21(3):193-4. PMID: 23457070
- Bozic KJ, Ong K, Lau E, Berry DJ, Vail TP, Kurtz SM, Rubash HE. Estimating risk in Medicare patients with THA: an electronic risk calculator for periprosthetic joint infection and mortality. Clin Orthop Relat Res. 2013 Feb; 471(2):574-83. PMID: 2317911
- Bozic KJ, Ward DT, Lau EC, Chan V, Wetters NG, Naziri Q, Odum S, Fehring TK, Mont MA, Gioe TJ, Della Valle CJ. Risk factors for periprosthetic joint infection following primary total hip arthroplasty: a case control study. J Arthroplasty. 2014 Jan; 29(1):154-6. PMID: 23702271