OsteoarthritisSPACERHIPNCT01373099
Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement
A study testing Implantation of a static, non-articulating cement spacer. and Implantation of an articulating spacer. in people with Osteoarthritis and Hip Infection, run by Rush University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis, Hip Infection, Prosthetic Joint Infection
- What is being tested?
- Implantation of a static, non-articulating cement spacer. and Implantation of an articulating spacer.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Diagnosis of periprosthetic joint infection of a primary total hip arthroplasty with a planned two-stage exchange procedure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Hip Infection
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.
Read the detailed 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.
- Conditions
- Osteoarthritis, Hip Infection, Prosthetic Joint Infection, Complications; Arthroplasty, Infection or Inflammation, Complications; Arthroplasty
- Being tested
- Implantation of a static, non-articulating cement spacer., Implantation of an articulating spacer.
- Keywords
- arthroplasty, hip replacement, Osteoarthritis, knee Infection, Prosthetic Joint Infection, Complications; Arthroplasty, Infection or Inflammation, Complications; Arthroplasty
- Medical subject headings
- Osteoarthritis, Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a static, non-articulating cement spacer.Procedure or surgery
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.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Static Spacer | Experimental | Patients in this group will be randomized to a static, nonarticulating, antibiotic-impregnated cement spacer. Receives: 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. Receives: Procedure: Implantation of an articulating spacer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: outcome will be collected until 2 years post-operatively
Secondary outcomes (2)
Operative time
Measured: at the time of spacer revision, which would be up to a maximumup to 2 years after patient enrollment
Hip dislocation rates
Measured: outcomes will be collected until 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, Central DuPage Hospital
- Responsible party
- Principal investigator, Peter N. Chalmers, MD, Rush University Medical Center
- Investigators
- Craig Della Valle, MD, Principal investigator, Rush University Medical CenterScott Sporer, MD, Principal investigator, Rush University Medical CenterPeter Chalmers, MD, Principal investigator, Rush University Medical CenterJavad Parvizi, MD, Principal investigator, Thomas Jefferson HospitalMatt Austin, MD, Principal investigator, Thomas Jefferson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373099
- Sponsor's protocol ID
- SPACERHIP
- Acronym
- SPACERHIP
- Status last verified
- Oct 2020
- First submitted
- 6 Jun 2011
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18534466Peersman 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.
PubMed 11716377Della 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.
PubMed 15057079Biring 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.
PubMed 19880885Hsieh 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.
PubMed 15342762Younger 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.
PubMed 9306211Anagnostakos 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.
PubMed 19404802Fink 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.
PubMed 20665141Lewis 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.
PubMed 17588247Affatato 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.
PubMed 12578213Gooding 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.
PubMed 20878287Haddad 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.
PubMed 10990301Wentworth 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.
PubMed 12479350Fehring 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.
PubMed 11064968Paprosky 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.
PubMed 8163974
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Hip Infection
- ClinicalTrials.gov ID
- NCT01373099
- Acronym / sponsor ID
- SPACERHIP / SPACERHIP
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, Central DuPage Hospital
- Study start
- Aug 2011
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static Spacer | Experimental | Procedure: Implantation of a static, non-articulating cement spacer.Patients in this group will be randomized to a static, nonarticulating, antibiotic-impregnated cement spacer. |
| Articulating spacer | Experimental | Procedure: Implantation of an articulating spacer.Patients in this group will be randomized to an articulating antibiotic-impregnated cement spacer. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Diagnosis of periprosthetic joint infection of a primary total hip arthroplasty with a planned two-stage exchange procedure.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Static Spacer |
| 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. | Procedure or surgery | Articulating spacer |
Primary outcome
Harris Hip Score
Time frame: outcome will be collected until 2 years post-operatively
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.
2 secondary outcomes
Operative time
Time frame: at the time of spacer revision, which would be up to a maximumup to 2 years after patient enrollment
Hip dislocation rates
Time frame: outcomes will be collected until 2 years post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 18534466Kurtz 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.
- Background: PubMed 11716377Peersman 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.
- Background: PubMed 15057079Della 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.
- Background: PubMed 19880885Biring 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.
- Background: PubMed 15342762Hsieh 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.
- Background: PubMed 9306211Younger 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.
- Background: PubMed 19404802Anagnostakos 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.
- Background: PubMed 20665141Fink 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.
- Background: PubMed 17588247Lewis 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.
- Background: PubMed 12578213Affatato 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.
- Background: PubMed 20878287Gooding 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.
- Background: PubMed 10990301Haddad 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.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Della Valle, MD principal investigator
Rush University Medical Center
Scott Sporer, MD principal investigator
Rush University Medical Center
Peter Chalmers, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of a static, non-articulating cement spacer. and Implantation of an articulating spacer. in people with Osteoarthritis and Hip Infection, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: outcome will be collected until 2 years post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373099, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.