Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection
NCT ID: NCT01373112
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
68 participants
INTERVENTIONAL
2011-12-31
2020-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement
NCT01373099
One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection
NCT02734134
Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis
NCT02405702
Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections
NCT01712880
Assessing Renal Function in Patients With an Antibiotic Laden Spacer
NCT01683734
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Post-operatively, all patients will be made touch-down weight bearing protected with a walker or crutches. If a static spacer is placed, patients will be immobilized using with a knee immobilizer. If an articulating spacer is utilized, range of motion will be allowed to the limits of stability as determined in the operating room and protected with a hinged knee brace. At the time of reoperation, the joint will be aspirated and multiple cultures obtained along with intraoperative histopathological analysis to evaluate for persistent infection.
Data collected preoperatively will include age, gender, laterality, etiology of knee degeneration, comorbidities, Knee Society score, and infecting organisms. The Knee Society score has been used extensively in the study of revision knee arthroplasty and has been found to be reliable and valid and will be determined pre-operatively and at all follow-up visits.
Data collected at the time of implant removal and reimplantation will include operative time, blood loss, and need for an extensile exposure. Radiographs performed immediately following and just prior to reimplantation will be reviewed to determine if the spacer utilized has caused bone loss; bone loss to the cut bony surfaces will be confirmed intraoperatively. At each follow-up visit radiographic appearance, the Knee Society Score, knee range of motion, recurrence of infection, and the need for revision or reoperation of any kind on the knee will be determined.
All portions of this study will be part of conventional care except for randomization to either a static or articulating spacer. Which type of spacer is used currently depends upon the judgment of the attending surgeons and both are used routinely.
The primary outcome variable will be range of motion. A power analysis was conducted with the assistance of Dr. Mario Moric at Rush using range of motion as our primary outcome variable, with standard deviations culled from two of the largest series to date -Van Thiel and colleagues (2010) and Fehring and colleagues (2000). For an 80% chance of detecting a predetermined clinically significant difference of 10 degrees, 53 patients per group, 106 patients total, will be needed. To account for attrition, our target sample size will be 140 patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Static Spacer
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
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.
Articulating Spacer
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
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Static Spacer
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.
Articulating Spacer
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central DuPage Hospital
OTHER
Joint Implant Surgeons, Inc.
OTHER
Thomas Jefferson University
OTHER
Rush University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter N. Chalmers, MD
Resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Chalmers, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Craig Della Valle, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Scott Sporer, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Adolph Lombardi, MD
Role: PRINCIPAL_INVESTIGATOR
Joint Implant Surgeons, Inc.
Keith Berend, MD
Role: PRINCIPAL_INVESTIGATOR
Joint Implant Surgeons, Inc.
Matt Austin, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rush University Medical Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPACERKNEE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.