- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02372435
Short Interval in Treatment of PJI (Fast-track)
Efficacy and Safety of Fast-track Treatment for Prosthetic Joint Infection (PJI)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antje Spranger
- Phone Number: +4930450652416
- Email: antje.spranger@charite.de
Study Contact Backup
- Name: Alessandra C Bardelli, M.Sc.PH
- Phone Number: +4930450552407
- Email: alessandra-catalina.bardelli@charite.de
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Short interval
Re-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm").
|
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.
|
Active Comparator: Long interval
Re-Implantation of the prosthesis after a Long interval of 6-10 weeks (standard surgical treatment).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection outcome
Time Frame: 12 months after surgery
|
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).
|
12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional outcome
Time Frame: 12 months after surgery
|
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).
|
12 months after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrej Trampuz, PD, Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChariteU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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