Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement

Osteoarthritis Clinical Trial

— SPACERHIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373099
• Other study ID #: SPACERHIP
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: August 2020

Study information

• Verified date: October 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Static spacers will be hand-made with a rod of antibiotic-impregnated cement and cement beads of sufficient quantity to fill the acetabulum.

Post-operatively, all patients will be made touch-down weight bearing protected with a walker or crutches. At the time of reimplantation, 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 hip degeneration, comorbidities, Harris Hip score, infecting organisms and Paprosky femoral and acetabular bone loss classification. The Harris Hip score has been used extensively in the study of revision hip arthroplasty and has been found to be reliable and valid and will be determined preoperatively and at all follow-up visits.

Data collected at the time of implant removal and reimplantation will include operative time, blood loss, surgical approach, and need for an extended trochanteric osteotomy. 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 visits radiographic appearance, the Harris Hip Score, dislocation events, recurrence of infection, and the need for revision or reoperation of any kind on the hip will be determined.

All portions of this study will be part of conventional care except for randomization and collection of the Harris Hip Score. 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 Harris Hip Score. A power analysis was conducted with the assistance of Dr. Mario Moric at Rush. Using the standard deviation of Harris Hip Scores from Hsieh and colleagues (2004) and Fehring and colleagues (1999), the largest previous studies reporting such data, Dr. Moric estimated 56 patients, 28 patients per group, would be needed to detect a clinically relevant difference of ten points. To account for attrition, our target total sample size will be 80 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• 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 periprosthetic joint infection of a primary total hip arthroplasty with a planned two-stage exchange procedure.

Exclusion Criteria:

1. Infection of a revision as opposed to a primary total hip 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Complications; Arthroplasty
• Complications; Arthroplasty, Infection or Inflammation
• Hip Infection
• Infection
• Inflammation
• Osteoarthritis
• Prosthetic Joint Infection

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	Central DuPage Hospital, Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

Della Valle CJ, Paprosky WG. The femur in revision total hip arthroplasty evaluation and classification. Clin Orthop Relat Res. 2004 Mar;(420):55-62. — 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

Fink B, Rechtenbach A, Büchner 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. — 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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Söderman 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time		at the time of spacer revision, which would be up to a maximumup to 2 years after patient enrollment
Secondary	Hip dislocation rates		outcomes will be collected until 2 years post-operatively