Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection

NCT01373112 | Completed

• 1 other identifier: SPACERKNEE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Infection remains a difficult-to-treat complication of total knee 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 typically is 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 the patient requires repeat debridement, a second operative procedure is performed. While the use of an antibiotic-loaded spacer is well accepted, whether the spacer should immobilize the knee (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of articulating spacers argue that they prevent scarring of the musculature surrounding the knee resulting in easier reimplantation, improved long-term knee function, and improved range of motion. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and is simpler to fashion intraoperatively. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters knee function, operative time, and range of motion. 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 knee arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, knee function, ease of reimplantation, and range of motion. The investigators hypothesize that articulating spacers will provide shorter operative times at reimplantation, while improving knee function and range of motion.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Range of motion

  Outcomes will be collected until 2 years post-operatively.

Secondary Outcomes (2)

• Knee Society Score

  Outcomes will be collected until 2 years post-operatively.

• Operative time

  Outcomes will be collected until 2 years post-operatively.

Study Arms (2)

Static Spacer

EXPERIMENTAL

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 a 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 the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 g of Tobramycin for each 40 g packet of cement. Static spacers will be hand-made to fit the femoral and tibial exposed metaphyses as a solid block with associated antibiotic cement coated tibial and femoral intramedullary rod, such that knee motion will be minimized.

Procedure: Static Spacer

Articulating Spacer

EXPERIMENTAL

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 a 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 the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 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).

Procedure: Articulating Spacer

Interventions

Static 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 a 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 the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 g of Tobramycin for each 40 g packet of cement. Static spacers will be hand-made to fit the femoral and tibial exposed metaphyses as a solid block with associated antibiotic cement coated tibial and femoral intramedullary rod, such that knee motion will be minimized.

Static Spacer

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 a 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 the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 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).

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 a periprosthetic joint infection of a primary total knee arthroplasty with a planned two-stage exchange procedure.

You may not qualify if:

• Infection of a revision as opposed to a primary total knee 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
• Central DuPage Hospital: collaborator
• Joint Implant Surgeons, Inc.: collaborator
• Thomas Jefferson University: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (21)

• 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

• Haleem AA, Berry DJ, Hanssen AD. Mid-term to long-term followup of two-stage reimplantation for infected total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):35-9. doi: 10.1097/01.blo.0000147713.64235.73.

  PMID: 15534516 BACKGROUND

• Van Thiel GS, Berend KR, Klein GR, Gordon AC, Lombardi AV, Della Valle CJ. Intraoperative molds to create an articulating spacer for the infected knee arthroplasty. Clin Orthop Relat Res. 2011 Apr;469(4):994-1001. doi: 10.1007/s11999-010-1644-6.

  PMID: 21042896 BACKGROUND

• Cuckler JM. The infected total knee: management options. J Arthroplasty. 2005 Jun;20(4 Suppl 2):33-6. doi: 10.1016/j.arth.2005.03.004.

  PMID: 15991126 BACKGROUND

• Goldman RT, Scuderi GR, Insall JN. 2-stage reimplantation for infected total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):118-24. doi: 10.1097/00003086-199610000-00016.

  PMID: 8895627 BACKGROUND

• Hirakawa K, Stulberg BN, Wilde AH, Bauer TW, Secic M. Results of 2-stage reimplantation for infected total knee arthroplasty. J Arthroplasty. 1998 Jan;13(1):22-8. doi: 10.1016/s0883-5403(98)90071-7.

  PMID: 9493534 BACKGROUND

• Emerson RH Jr, Muncie M, Tarbox TR, Higgins LL. Comparison of a static with a mobile spacer in total knee infection. Clin Orthop Relat Res. 2002 Nov;(404):132-8. doi: 10.1097/00003086-200211000-00023.

  PMID: 12439251 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

• Freeman MG, Fehring TK, Odum SM, Fehring K, Griffin WL, Mason JB. Functional advantage of articulating versus static spacers in 2-stage revision for total knee arthroplasty infection. J Arthroplasty. 2007 Dec;22(8):1116-21. doi: 10.1016/j.arth.2007.04.009.

  PMID: 18078879 BACKGROUND

• Hsu YC, Cheng HC, Ng TP, Chiu KY. Antibiotic-loaded cement articulating spacer for 2-stage reimplantation in infected total knee arthroplasty: a simple and economic method. J Arthroplasty. 2007 Oct;22(7):1060-6. doi: 10.1016/j.arth.2007.04.028.

  PMID: 17920482 BACKGROUND

• Jamsen E, Sheng P, Halonen P, Lehto MU, Moilanen T, Pajamaki J, Puolakka T, Konttinen YT. Spacer prostheses in two-stage revision of infected knee arthroplasty. Int Orthop. 2006 Aug;30(4):257-61. doi: 10.1007/s00264-006-0102-2. Epub 2006 Mar 25.

  PMID: 16565839 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

• Hart WJ, Jones RS. Two-stage revision of infected total knee replacements using articulating cement spacers and short-term antibiotic therapy. J Bone Joint Surg Br. 2006 Aug;88(8):1011-5. doi: 10.1302/0301-620X.88B8.17445.

  PMID: 16877598 BACKGROUND

• Hofmann AA, Kane KR, Tkach TK, Plaster RL, Camargo MP. Treatment of infected total knee arthroplasty using an articulating spacer. Clin Orthop Relat Res. 1995 Dec;(321):45-54.

  PMID: 7497685 BACKGROUND

• Meek RM, Dunlop D, Garbuz DS, McGraw R, Greidanus NV, Masri BA. Patient satisfaction and functional status after aseptic versus septic revision total knee arthroplasty using the PROSTALAC articulating spacer. J Arthroplasty. 2004 Oct;19(7):874-9. doi: 10.1016/j.arth.2004.06.028.

  PMID: 15483804 BACKGROUND

• Calton TF, Fehring TK, Griffin WL. Bone loss associated with the use of spacer blocks in infected total knee arthroplasty. Clin Orthop Relat Res. 1997 Dec;(345):148-54.

  PMID: 9418632 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

• Asif S, Choon DS. Midterm results of cemented Press Fit Condylar Sigma total knee arthroplasty system. J Orthop Surg (Hong Kong). 2005 Dec;13(3):280-4. doi: 10.1177/230949900501300311.

  PMID: 16365492 BACKGROUND

• Ghanem E, Pawasarat I, Lindsay A, May L, Azzam K, Joshi A, Parvizi J. Limitations of the Knee Society Score in evaluating outcomes following revision total knee arthroplasty. J Bone Joint Surg Am. 2010 Oct 20;92(14):2445-51. doi: 10.2106/JBJS.I.00252.

  PMID: 20962195 BACKGROUND

• Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

  PMID: 2805470 BACKGROUND

• Liow RY, Walker K, Wajid MA, Bedi G, Lennox CM. The reliability of the American Knee Society Score. Acta Orthop Scand. 2000 Dec;71(6):603-8. doi: 10.1080/000164700317362244.

  PMID: 11145388 BACKGROUND

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

• Peter Chalmers, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Craig Della Valle, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Scott Sporer, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Adolph Lombardi, MD

  Joint Implant Surgeons, Inc.

  PRINCIPAL INVESTIGATOR

• Keith Berend, MD

  Joint Implant Surgeons, Inc.

  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: December 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)