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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 June 2013 |
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Main ID: |
NCT01373099 |
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Date of registration:
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06/06/2011 |
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Primary sponsor: |
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Public title:
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Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement
SPACERHIP |
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Scientific title:
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Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Hip Infection |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01373099 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter N Chalmers, MD |
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Address:
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Telephone:
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3129425000 |
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Email:
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peter_chalmers@rush.edu |
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Affiliation:
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Name:
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Craig Della Valle, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush University Medical Center |
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Name:
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Peter Chalmers, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush University Medical Center |
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Name:
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Scott Sporer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush University Medical Center |
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Name:
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Javad Parvizi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thomas Jefferson Hospital |
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Name:
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Matt Austin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thomas Jefferson Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complications; Arthroplasty
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Complications; Arthroplasty, Infection or Inflammation
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Hip Infection
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Osteoarthritis
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Prosthetic Joint Infection
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Intervention(s)
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Procedure: Implantation of a static, non-articulating cement spacer.
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Procedure: Implantation of an articulating spacer.
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Primary Outcome(s)
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Harris Hip Score
[Time Frame: outcome will be collected until 2 years post-operatively]
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Secondary Outcome(s)
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Hip dislocation rates
[Time Frame: outcomes will be collected until 2 years post-operatively]
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Operative time
[Time Frame: at the time of spacer revision, which would be up to a maximumup to 2 years after patient enrollment]
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Secondary ID(s)
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SPACERHIP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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