One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

NCT02734134 | Active Not Recruiting DMC

• 1 other identifier: 1106
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Surgical Site Infection

Keywords

Periprosthetic joint infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Health Related Quality of Health

  2 years following surgery

• Patient-Reported Functional Outcomes

  2 years following surgery

• Patient-Reported Functional Outcomes

  2 years following surgery

Other Outcomes (2)

• Death

  2 years

• Percentage of patients requiring surgical revision for causes other than infection

  Two years

Study Arms (2)

One-stage exchange

ACTIVE COMPARATOR

One surgery where the infected implants are removed and the hip or knee joint are 'washed out' before new joint replacement implants are re-implanted during the same surgical procedure.

Procedure: One-stage exchange joint replacement surgery

Two-stage exchange

ACTIVE COMPARATOR

Two surgeries; during the first surgery the infected implants are removed and a spacer is placed in the hip or knee joint in place of the implants. A second surgery to re-implant the hip or knee joint replacement implants is performed if and when the infection has cleared.

Procedure: Two-stage exchange joint replacement surgery

Interventions

One-stage exchange joint replacement surgery PROCEDURE

One-stage exchange

Two-stage exchange joint replacement surgery PROCEDURE

Two-stage exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

Midwest Orthopaedics at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

OrthoCarolina Research Institue

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Rothman Institute at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (17)

• 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.

  PMID: 24352771 BACKGROUND

• 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.

  PMID: 23578491 BACKGROUND

• 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.

  PMID: 19458950 BACKGROUND

• 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.

  PMID: 18754743 BACKGROUND

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

  PMID: 20839679 BACKGROUND

• 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.

  PMID: 20719522 BACKGROUND

• 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.

  PMID: 1876406 BACKGROUND

• 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.

  PMID: 15132327 BACKGROUND

• 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.

  PMID: 22081299 BACKGROUND

• 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.

  PMID: 9698000 BACKGROUND

• 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.

  PMID: 9795805 BACKGROUND

• 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.

  PMID: 21116817 BACKGROUND

• 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.

  PMID: 22983683 BACKGROUND

• 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.

  PMID: 23440616 BACKGROUND

• 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.

  PMID: 11861721 BACKGROUND

• 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.

  PMID: 23218429 BACKGROUND

• 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.

  PMID: 23531512 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas K Fehring, MD

  Attending Hip & Knee Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 12, 2016
• Study Start: May 18, 2016
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2026
• Last Updated: April 28, 2025

Record last verified: 2025-04

Locations

US (5)