Short Interval in Treatment of PJI (Fast-track)
Primary Purpose
Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection, Shoulder Prosthetic Joint Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shortening of the interval of two-stage prosthesis exchange
Sponsored by
About this trial
This is an interventional treatment trial for Hip Prosthetic Joint Infection focused on measuring PJI
Eligibility Criteria
Inclusion Criteria:
- Subjects aged ≥18 years with hip, knee or shoulder PJI, in whom all prosthetic components are removed.
- The standard treatment for systemic and local antibiotics is followed (predetermined algorithm).
- Subjects are willing to participate in the study (signed informed consent) and comply with planned follow-up assessments (at 3, 6 and 12 months after study inclusion).
Exclusion Criteria:
- Treatment with debridement and prosthesis retention (e.g. performed in early postoperative or acute hematogenous infections with symptom duration <3 weeks) or one-stage exchange.
- PJI caused by difficult-to-treat organisms, including rifampin-resistant staphylococci, quinolone-resistant Gram-negative bacilli and fungi.
- Subject previously enrolled in this study or is currently enrolled in another competitive investigational study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Short interval
Long interval
Arm Description
Re-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm").
Re-Implantation of the prosthesis after a Long interval of 6-10 weeks (standard surgical treatment).
Outcomes
Primary Outcome Measures
Infection outcome
Duration of infection-free interval and frequency of adverse events related to surgical treatment. The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).
Secondary Outcome Measures
Functional outcome
The functional assessment will be performed using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient mobility / independency in daily life, subjective evaluation of pain using a visual analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).
Full Information
NCT ID
NCT02372435
First Posted
January 23, 2015
Last Updated
February 20, 2015
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT02372435
Brief Title
Short Interval in Treatment of PJI
Acronym
Fast-track
Official Title
Efficacy and Safety of Fast-track Treatment for Prosthetic Joint Infection (PJI)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange Revision.
Patients will be randomized into 2 groups: the experimental Group will get a reimplantation after a short interval (2-3 weeks) while the control Group after a long standard interval.
Primary objective of the study is "Infection outcome". The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).
Secondary objective is "Functional outcome".The functional assessment will be performed using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient mobility / independency in daily life, subjective evaluation of pain using a visual analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).
Detailed Description
A two-stage prosthesis exchange after a long interval of ≥6 weeks is considered the "gold standard" for management of prosthetic joint infection (PJI). We will compare the efficacy and safety of a novel surgical approach with short interval of 2-3 weeks ("fast-track") compared to the standard long interval of 6-10 weeks. Included will be patients with hip, knee or shoulder PJI, in whom all prosthetic components are removed; excluded will be patients treated with prosthesis retention or one-stage exchange and PJI caused by difficult-to-treat organisms. Patients will be randomized into short versus long interval surgical procedure, using a standard antibiotic regimen of 12 weeks in both study arms. The recruitment period of this multicenter treatment/outcome trial is 24 months, follow-up period 12 months and the calculated sample size 418 patients (i.e. 209 patient for each study arm). Primary endpoint is the infection outcome, secondary endpoint is the functional outcome, defined by established scores for joint-specific scores, pain and quality of life scores. The expected outcomes in the short interval ("fast-track") arm are (i) improved infection outcome (i.e. longer infection-free period and less treatment-related adverse events); (ii) improved functional outcome, and (iii) reduced healthcare expenses. In addition, pharmacokinetic studies will be performed and a biobank of microbes and biological samples will be established. This study has high clinical relevance for an increasing public health challenge related to device-associated infections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection, Shoulder Prosthetic Joint Infection
Keywords
PJI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short interval
Arm Type
Experimental
Arm Description
Re-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm").
Arm Title
Long interval
Arm Type
Active Comparator
Arm Description
Re-Implantation of the prosthesis after a Long interval of 6-10 weeks (standard surgical treatment).
Intervention Type
Procedure
Intervention Name(s)
Shortening of the interval of two-stage prosthesis exchange
Intervention Description
The Intervention consist in shortening of the interval between Explantation and re-implantation in patients undergoing a two-stage prosthesis Exchange. Comparison between arms is performed between short and long interval before re-implantation.
Primary Outcome Measure Information:
Title
Infection outcome
Description
Duration of infection-free interval and frequency of adverse events related to surgical treatment. The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Functional outcome
Description
The functional assessment will be performed using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient mobility / independency in daily life, subjective evaluation of pain using a visual analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects aged ≥18 years with hip, knee or shoulder PJI, in whom all prosthetic components are removed.
The standard treatment for systemic and local antibiotics is followed (predetermined algorithm).
Subjects are willing to participate in the study (signed informed consent) and comply with planned follow-up assessments (at 3, 6 and 12 months after study inclusion).
Exclusion Criteria:
Treatment with debridement and prosthesis retention (e.g. performed in early postoperative or acute hematogenous infections with symptom duration <3 weeks) or one-stage exchange.
PJI caused by difficult-to-treat organisms, including rifampin-resistant staphylococci, quinolone-resistant Gram-negative bacilli and fungi.
Subject previously enrolled in this study or is currently enrolled in another competitive investigational study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antje Spranger
Phone
+4930450652416
Email
antje.spranger@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra C Bardelli, M.Sc.PH
Phone
+4930450552407
Email
alessandra-catalina.bardelli@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Trampuz, PD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Short Interval in Treatment of PJI
We'll reach out to this number within 24 hrs