Osteoarthritis Clinical Trial
Official title:
Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection
NCT number | NCT01373112 |
Other study ID # | SPACERKNEE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2011 |
Est. completion date | August 2020 |
Verified date | October 2020 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1) Diagnosis of a periprosthetic joint infection of a primary total knee arthroplasty with a planned two-stage exchange procedure. Exclusion Criteria: 1. Infection of a revision as opposed to a primary total knee arthroplasty 2. Medically unfit for operative intervention 3. Extensive bone loss preventing the use of an articulating spacer 4. Soft tissue defects that prevent the use of an articulating spacer 5. Known allergy to polymethylmethacrylate, tobramycin or vancomycin. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Central DuPage Hospital, Joint Implant Surgeons, Inc., Thomas Jefferson University |
United States,
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. — View Citation
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. — View Citation
Cuckler JM. The infected total knee: management options. J Arthroplasty. 2005 Jun;20(4 Suppl 2):33-6. Review. — View Citation
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. — View Citation
Fehring TK, Calton TF, Griffin WL. Cementless fixation in 2-stage reimplantation for periprosthetic sepsis. J Arthroplasty. 1999 Feb;14(2):175-81. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Goldman RT, Scuderi GR, Insall JN. 2-stage reimplantation for infected total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):118-24. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Jämsen E, Sheng P, Halonen P, Lehto MU, Moilanen T, Pajamäki J, Puolakka T, Konttinen YT. Spacer prostheses in two-stage revision of infected knee arthroplasty. Int Orthop. 2006 Aug;30(4):257-61. Epub 2006 Mar 25. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion | Outcomes will be collected until 2 years post-operatively. | ||
Secondary | Knee Society Score | Outcomes will be collected until 2 years post-operatively. | ||
Secondary | Operative time | Outcomes will be collected until 2 years post-operatively. |
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