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Short Interval in Treatment of PJI (Fast-track)

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ClinicalTrials.gov Identifier: NCT02372435
Recruitment Status : Unknown
Verified February 2015 by Andrej Trampuz, Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Andrej Trampuz, Charite University, Berlin, Germany

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).


Condition or disease Intervention/treatment Phase
Hip Prosthetic Joint Infection Knee Prosthetic Joint Infection Shoulder Prosthetic Joint Infection Procedure: Shortening of the interval of two-stage prosthesis exchange Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fast-track Treatment for Prosthetic Joint Infection (PJI)
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short interval
Re-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm").
Procedure: Shortening of the interval of two-stage prosthesis exchange
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).
Procedure: Shortening of the interval of two-stage prosthesis exchange
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 Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372435


Contacts
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Contact: Antje Spranger +4930450652416 antje.spranger@charite.de
Contact: Alessandra C Bardelli, M.Sc.PH +4930450552407 alessandra-catalina.bardelli@charite.de

Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andrej Trampuz, PD Charite University, Berlin, Germany

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Responsible Party: Andrej Trampuz, PD Dr. Andrej Trampuz, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02372435     History of Changes
Other Study ID Numbers: ChariteU
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Andrej Trampuz, Charite University, Berlin, Germany:
PJI

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases