One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

Surgical Site Infection Clinical Trial

Official title:

One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02734134
• Other study ID #: 1106
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 18, 2016
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the outcomes of two different treatment options commonly used to manage periprosthetic joint infection (PJI), an infection around the artificial knee or hip.

Description:

Total joint arthroplasty (TJA) is a very common and successful procedure, and is expected to become more prevalent in the upcoming years. However, despite its success, TJA is associated with some complications, including periprosthetic joint infection (PJI). PJI is a devastating complication that is associated with marked patient morbidity and mortality and is an immense economic burden. Although the rate of PJI following a TJA is low, the burden is rising exponentially due to health complications and treatment costs. There are two common types of surgical treatments that can be used to treat chronic PJI, a two-stage exchange arthroplasty and a one-stage exchange arthroplasty. During a two-stage exchange arthroplasty, the implants are removed, infected tissues are debrided and a temporary antibiotic impregnated spacer fashioned from polymethylmethacrylate is placed (stage one). Afterwards the patient undergoes many weeks of intravenous antibiotics, followed by reimplantation at a later date (stage two). During the time between the first and second stage of the revision patients are often immobile, experience severe pain due to a lack of functioning joint, and may experience systemic toxicity associated with the administration of antibiotics. In a one stage exchange arthroplasty, the infected prosthesis is removed, infected tissues are debrided, and a new prosthesis is reimplanted during the same procedure. While the two-stage exchange arthroplasty is the preferred method of treatment for chronic PJI in North America, the one-stage exchange arthroplasty is the method of choice in Europe and some centers have reported comparable results in terms of success for one-stage exchange to two-stage exchange arthroplasty. However, there has been no randomized, prospective, controlled study to date that compares one-stage exchange to two-stage exchange arthroplasty. Because of the lack of comparative outcome reports, and the perceived higher rate of failure of one-stage exchange arthroplasty, surgeons in North America prefer to perform the traditional two-stage exchange arthroplasty for management of chronic PJI. Several teams have succeeded in performing a one-stage exchange arthroplasty in selected patients, but this procedure has not gained much popularity in the US. The purpose of this study 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 343
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients >18 years old
• Patients who speak English and are willing to sign the consent form
• Patients with chronic infection of a total knee or total hip arthroplasty, defined as:
• A sinus communicating with the prosthesis
• Two positive cultures obtained from the prosthesis
• 3 of 5 criteria: (i) Elevated erythrocyte sedimentation rate (ESR) (>30mm/jr) and c-reactive protein (CRP) (>10mg/L) (ii) Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip (iii) Elevated synovial neutrophil percentage (>80%) (iv) One positive culture (v) Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
• Patients with a previous irrigation and debridement for periprosthetic infection

Exclusion Criteria:

• Culture negative infections whereby the infecting organism has not identified
• Patients with systemic sepsis who require emergent surgery
• Patients with extensive soft tissue involvement that would preclude the closure of the wound after reimplantation, if the patient were to undergo the one-stage exchange
• Patients with acute PJI or acute hematogenous PJI, defined as:
• Presentation of systems <4 weeks from index procedure
• Presentation of systems <4 week duration
• Fungal infections
• Resistant organisms not sensitive to available IV antibiotics, oral antibiotics, or heat stable antibiotic additives to bone cement with documented elution characteristics
• Revision surgery or previous two-stage reimplant
• HIV positive patients or patients on chemotherapy

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• One-stage exchange joint replacement surgery

• Two-stage exchange joint replacement surgery

Locations

Country	Name	City	State
United States	OrthoCarolina Research Institue	Charlotte	North Carolina
United States	Midwest Orthopaedics at Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Hospital for Special Surgery	New York	New York
United States	Rothman Institute at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (14)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.	Carilion Clinic, Cleveland Clinic Florida, Emory University, Hospital for Special Surgery, New York, Midwest Orthopaedics Rush University Medical Center, Ochsner Health System, Rothman Institute at Thomas Jefferson University, The Cleveland Clinic, University of California, San Francisco, University of Iowa, University of Southern California, University of Utah, Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (17)

Aggarwal VK, Rasouli MR, Parvizi J. Periprosthetic joint infection: Current concept. Indian J Orthop. 2013 Jan;47(1):10-7. doi: 10.4103/0019-5413.106884. — View Citation

Berend KR, Lombardi AV Jr, Morris MJ, Bergeson AG, Adams JB, Sneller MA. Two-stage treatment of hip periprosthetic joint infection is associated with a high rate of infection control but high mortality. Clin Orthop Relat Res. 2013 Feb;471(2):510-8. doi: 10.1007/s11999-012-2595-x. — View Citation

Berry DJ, Harmsen WS, Cabanela ME, Morrey BF. Twenty-five-year survivorship of two thousand consecutive primary Charnley total hip replacements: factors affecting survivorship of acetabular and femoral components. J Bone Joint Surg Am. 2002 Feb;84(2):171-7. doi: 10.2106/00004623-200202000-00002. — View Citation

Buechel FF, Femino FP, D'Alessio J. Primary exchange revision arthroplasty for infected total knee replacement: a long-term study. Am J Orthop (Belle Mead NJ). 2004 Apr;33(4):190-8; discussion 198. — View Citation

Daigle ME, Weinstein AM, Katz JN, Losina E. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol. 2012 Oct;26(5):649-58. doi: 10.1016/j.berh.2012.07.013. — View Citation

Diaz-Ledezma C, Higuera CA, Parvizi J. Success after treatment of periprosthetic joint infection: a Delphi-based international multidisciplinary consensus. Clin Orthop Relat Res. 2013 Jul;471(7):2374-82. doi: 10.1007/s11999-013-2866-1. Epub 2013 Feb 26. — View Citation

El Helou OC, Berbari EF, Marculescu CE, El Atrouni WI, Razonable RR, Steckelberg JM, Hanssen AD, Osmon DR. Outcome of enterococcal prosthetic joint infection: is combination systemic therapy superior to monotherapy? Clin Infect Dis. 2008 Oct 1;47(7):903-9. doi: 10.1086/591536. — View Citation

Leunig M, Chosa E, Speck M, Ganz R. A cement spacer for two-stage revision of infected implants of the hip joint. Int Orthop. 1998;22(4):209-14. doi: 10.1007/s002640050244. — View Citation

Luu A, Syed F, Raman G, Bhalla A, Muldoon E, Hadley S, Smith E, Rao M. Two-stage arthroplasty for prosthetic joint infection: a systematic review of acute kidney injury, systemic toxicity and infection control. J Arthroplasty. 2013 Oct;28(9):1490-8.e1. doi: 10.1016/j.arth.2013.02.035. Epub 2013 Apr 8. — View Citation

Nickinson RS, Board TN, Gambhir AK, Porter ML, Kay PR. The microbiology of the infected knee arthroplasty. Int Orthop. 2010 Apr;34(4):505-10. doi: 10.1007/s00264-009-0797-y. Epub 2009 May 21. — View Citation

Parkinson RW, Kay PR, Rawal A. A case for one-stage revision in infected total knee arthroplasty? Knee. 2011 Jan;18(1):1-4. doi: 10.1016/j.knee.2010.04.008. Epub 2010 Aug 17. — View Citation

Parvizi J, Zmistowski B, Adeli B. Periprosthetic joint infection: treatment options. Orthopedics. 2010 Sep 7;33(9):659. doi: 10.3928/01477447-20100722-42. — View Citation

Pattyn C, De Geest T, Ackerman P, Audenaert E. Preformed gentamicin spacers in two-stage revision hip arthroplasty: functional results and complications. Int Orthop. 2011 Oct;35(10):1471-6. doi: 10.1007/s00264-010-1172-8. Epub 2010 Nov 30. — View Citation

Singer J, Merz A, Frommelt L, Fink B. High rate of infection control with one-stage revision of septic knee prostheses excluding MRSA and MRSE. Clin Orthop Relat Res. 2012 May;470(5):1461-71. doi: 10.1007/s11999-011-2174-6. Epub 2011 Nov 12. — View Citation

Ure KJ, Amstutz HC, Nasser S, Schmalzried TP. Direct-exchange arthroplasty for the treatment of infection after total hip replacement. An average ten-year follow-up. J Bone Joint Surg Am. 1998 Jul;80(7):961-8. doi: 10.2106/00004623-199807000-00004. — View Citation

von Foerster G, Kluber D, Kabler U. [Mid- to long-term results after treatment of 118 cases of periprosthetic infections after knee joint replacement using one-stage exchange surgery]. Orthopade. 1991 Jun;20(3):244-52. German. — View Citation

Zmistowski B, Karam JA, Durinka JB, Casper DS, Parvizi J. Periprosthetic joint infection increases the risk of one-year mortality. J Bone Joint Surg Am. 2013 Dec 18;95(24):2177-84. doi: 10.2106/JBJS.L.00789. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	Death within two years of surgical treatment for periprosthetic joint infection.	2 years
Other	Percentage of patients requiring surgical revision for causes other than infection	Revision of prosthetic joint for causes other than infection (e.g. hematoma, spacer dislocation).	Two years
Primary	Recurrence of infection	The primary outcome measured will be the recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the International Consensus Meeting on PJI (1 year follow-up).	1 year following treatment
Secondary	Health Related Quality of Health	All patients will complete the Veteran's Rand - 12 (VR-12) which is a general health measure. The VR-12 also yields a health utility measure that can be used to calculate quality-adjusted life years in an economic cost-utility analysis.	2 years following surgery
Secondary	Patient-Reported Functional Outcomes	Hip patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS), Junior which is a region-specific measure of pain and function of the hip.	2 years following surgery
Secondary	Patient-Reported Functional Outcomes	Knee patients will complete the Knee injury and Osteoarthritis Outcome Score (KOOS) Junior which is a region-specific measure of pain and function of the knee.	2 years following surgery