Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement

NCT01373099 | Completed DMC

• 1 other identifier: SPACERHIP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Infection remains one of the most difficult-to-treat complications of total hip arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants.The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary antibiotic-impregnated cement spacer. This spacer is typically left in place six weeks, during which time the patient receives intravenous antibiotics. After the surgeon feels that the infection has been eradicated, or if a second debridement is required, a second operative procedure is performed. While the use of an antibiotic spacer is well accepted, whether the spacer should immobilize the hip (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and that these spacers are simpler to fashion intraoperatively. Proponents of articulating spacers argue that they improve hip function, prevent damage to the musculature surrounding the hip, allow easier reimplantation, improve hip function, and prevent dislocation following hip reimplantation. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters hip function, operative time, and dislocation rates. Equipoise exists within the literature, and no randomized clinical trial has been conducted to evaluate this issue. The purpose of this study is to compare articulating and static antibiotic-impregnated spacers for the treatment of chronic periprosthetic infection complicating total hip arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, hip function, ease of reimplantation, and dislocation rates. The investigators hypothesize that articulating spacers will provide shorter operative times at replantation while improving hip function and hip dislocation rates following hip reimplantation.

Conditions

Osteoarthritis; Hip Infection; Prosthetic Joint Infection; Complications; Arthroplasty, Infection or Inflammation; Complications; Arthroplasty

Keywords

arthroplasty; hip replacement; Osteoarthritis; knee Infection; Prosthetic Joint Infection; Complications; Arthroplasty, Infection or Inflammation; Complications; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  The Harris Hip score has been used extensively in the study of revision hip arthroplasty and has been found to be reliable and valid to determine hip arthroplasty outcomes.

  outcome will be collected until 2 years post-operatively

Secondary Outcomes (2)

• Operative time

  at the time of spacer revision, which would be up to a maximumup to 2 years after patient enrollment

• Hip dislocation rates

  outcomes will be collected until 2 years post-operatively

Study Arms (2)

Static Spacer

EXPERIMENTAL

Patients in this group will be randomized to a static, nonarticulating, antibiotic-impregnated cement spacer.

Procedure: Implantation of a static, non-articulating cement spacer.

Articulating spacer

EXPERIMENTAL

Patients in this group will be randomized to an articulating antibiotic-impregnated cement spacer.

Procedure: Implantation of an articulating spacer.

Interventions

Implantation of a static, non-articulating cement spacer. PROCEDURE

After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed using 3.0 g of Vancomycin and 1.0 g of Tobramycin for each 40 g packet of cement. Static spacers will be hand-made with a rod of antibiotic-impregnated cement and cement beads of sufficient quantity to fill the acetabulum.

Static Spacer

Implantation of an articulating spacer. PROCEDURE

After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed using 3.0 g of Vancomycin and 1.0 g of Tobramycin for each 40 g packet of cement. Articulating spacers will be formed of antibiotic-impregnated cement using the Stage One system (Biomet, Warsaw, IN) sized to fit the endosteal and acetabular bone defect.

Articulating spacer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Diagnosis of periprosthetic joint infection of a primary total hip arthroplasty with a planned two-stage exchange procedure.

You may not qualify if:

• Infection of a revision as opposed to a primary total hip arthroplasty
• Medically unfit for operative intervention
• Extensive bone loss preventing the use of an articulating spacer
• Soft-tissue defects that prevent the use of an articulating spacer
• Known allergy to polymethylmethacrylate, tobramycin or vancomycin.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Thomas Jefferson University: collaborator
• Central DuPage Hospital: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (19)

• Kurtz SM, Lau E, Schmier J, Ong KL, Zhao K, Parvizi J. Infection burden for hip and knee arthroplasty in the United States. J Arthroplasty. 2008 Oct;23(7):984-91. doi: 10.1016/j.arth.2007.10.017. Epub 2008 Apr 10.

  PMID: 18534466 BACKGROUND

• Peersman G, Laskin R, Davis J, Peterson M. Infection in total knee replacement: a retrospective review of 6489 total knee replacements. Clin Orthop Relat Res. 2001 Nov;(392):15-23.

  PMID: 11716377 BACKGROUND

• Della Valle CJ, Paprosky WG. The femur in revision total hip arthroplasty evaluation and classification. Clin Orthop Relat Res. 2004 Mar;(420):55-62. doi: 10.1097/00003086-200403000-00009.

  PMID: 15057079 BACKGROUND

• Biring GS, Kostamo T, Garbuz DS, Masri BA, Duncan CP. Two-stage revision arthroplasty of the hip for infection using an interim articulated Prostalac hip spacer: a 10- to 15-year follow-up study. J Bone Joint Surg Br. 2009 Nov;91(11):1431-7. doi: 10.1302/0301-620X.91B11.22026.

  PMID: 19880885 BACKGROUND

• Hsieh PH, Shih CH, Chang YH, Lee MS, Shih HN, Yang WE. Two-stage revision hip arthroplasty for infection: comparison between the interim use of antibiotic-loaded cement beads and a spacer prosthesis. J Bone Joint Surg Am. 2004 Sep;86(9):1989-97.

  PMID: 15342762 BACKGROUND

• Younger AS, Duncan CP, Masri BA, McGraw RW. The outcome of two-stage arthroplasty using a custom-made interval spacer to treat the infected hip. J Arthroplasty. 1997 Sep;12(6):615-23. doi: 10.1016/s0883-5403(97)90133-9.

  PMID: 9306211 BACKGROUND

• Anagnostakos K, Wilmes P, Schmitt E, Kelm J. Elution of gentamicin and vancomycin from polymethylmethacrylate beads and hip spacers in vivo. Acta Orthop. 2009 Apr;80(2):193-7. doi: 10.3109/17453670902884700.

  PMID: 19404802 BACKGROUND

• Fink B, Rechtenbach A, Buchner H, Vogt S, Hahn M. Articulating spacers used in two-stage revision of infected hip and knee prostheses abrade with time. Clin Orthop Relat Res. 2011 Apr;469(4):1095-102. doi: 10.1007/s11999-010-1479-1. Epub 2010 Jul 28.

  PMID: 20665141 BACKGROUND

• Lewis G. Alternative acrylic bone cement formulations for cemented arthroplasties: present status, key issues, and future prospects. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):301-19. doi: 10.1002/jbm.b.30873.

  PMID: 17588247 BACKGROUND

• Affatato S, Mattarozzi A, Taddei P, Robotti P, Soffiatti R, Sudanese A, Toni A. Investigations on the wear behaviour of the temporary PMMA-based hip Spacer-G. Proc Inst Mech Eng H. 2003;217(1):1-8. doi: 10.1243/095441103762597665.

  PMID: 12578213 BACKGROUND

• Gooding CR, Masri BA, Duncan CP, Greidanus NV, Garbuz DS. Durable infection control and function with the PROSTALAC spacer in two-stage revision for infected knee arthroplasty. Clin Orthop Relat Res. 2011 Apr;469(4):985-93. doi: 10.1007/s11999-010-1579-y.

  PMID: 20878287 BACKGROUND

• Haddad FS, Masri BA, Campbell D, McGraw RW, Beauchamp CP, Duncan CP. The PROSTALAC functional spacer in two-stage revision for infected knee replacements. Prosthesis of antibiotic-loaded acrylic cement. J Bone Joint Surg Br. 2000 Aug;82(6):807-12. doi: 10.1302/0301-620x.82b6.10486.

  PMID: 10990301 BACKGROUND

• Wentworth SJ, Masri BA, Duncan CP, Southworth CB. Hip prosthesis of antibiotic-loaded acrylic cement for the treatment of infections following total hip arthroplasty. J Bone Joint Surg Am. 2002;84-A Suppl 2:123-8. doi: 10.2106/00004623-200200002-00017. No abstract available.

  PMID: 12479350 BACKGROUND

• Fehring TK, Odum S, Calton TF, Mason JB. Articulating versus static spacers in revision total knee arthroplasty for sepsis. The Ranawat Award. Clin Orthop Relat Res. 2000 Nov;(380):9-16. doi: 10.1097/00003086-200011000-00003.

  PMID: 11064968 BACKGROUND

• Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x.

  PMID: 8163974 BACKGROUND

• Shields RK, Enloe LJ, Evans RE, Smith KB, Steckel SD. Reliability, validity, and responsiveness of functional tests in patients with total joint replacement. Phys Ther. 1995 Mar;75(3):169-76; discussion 176-9. doi: 10.1093/ptj/75.3.169.

  PMID: 7870749 BACKGROUND

• Soderman P, Malchau H. Is the Harris hip score system useful to study the outcome of total hip replacement? Clin Orthop Relat Res. 2001 Mar;(384):189-97. doi: 10.1097/00003086-200103000-00022.

  PMID: 11249165 BACKGROUND

• Fehring TK, Calton TF, Griffin WL. Cementless fixation in 2-stage reimplantation for periprosthetic sepsis. J Arthroplasty. 1999 Feb;14(2):175-81. doi: 10.1016/s0883-5403(99)90122-5.

  PMID: 10065723 BACKGROUND

• Nahhas CR, Chalmers PN, Parvizi J, Sporer SM, Deirmengian GK, Chen AF, Culvern CN, Moric M, Della Valle CJ. Randomized Trial of Static and Articulating Spacers for Treatment of the Infected Total Hip Arthroplasty. J Arthroplasty. 2021 Jun;36(6):2171-2177. doi: 10.1016/j.arth.2021.01.031. Epub 2021 Jan 21.

  PMID: 33581975 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Infections; Inflammation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig Della Valle, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Scott Sporer, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Chalmers, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Javad Parvizi, MD

  Thomas Jefferson Hospital

  PRINCIPAL INVESTIGATOR

• Matt Austin, MD

  Thomas Jefferson Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 14, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)