Hip Prosthetic Joint InfectionFast-trackNCT02372435
Short Interval in Treatment of PJI
A study testing Shortening of the interval of two-stage prosthesis exchange in people with Hip Prosthetic Joint Infection and Knee Prosthetic Joint Infection, run by Charite University, Berlin, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection, Shoulder Prosthetic Joint Infection
- What is being tested?
- Shortening of the interval of two-stage prosthesis exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection, Shoulder Prosthetic Joint Infection
- Being tested
- Shortening of the interval of two-stage prosthesis exchange
- Keywords
- PJI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortening of the interval of two-stage prosthesis exchangeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Short interval | Experimental | Re-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm"). Receives: Procedure: Shortening of the interval of two-stage prosthesis exchange |
| Long interval | Active comparator | Re-Implantation of the prosthesis after a Long interval of 6-10 weeks (standard surgical treatment). Receives: Procedure: Shortening of the interval of two-stage prosthesis exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after surgery
Secondary outcomes (1)
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).
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Prosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Trampuz, Charite University, Berlin, Germany
- Investigators
- Andrej Trampuz, PD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372435
- Sponsor's protocol ID
- ChariteU
- Acronym
- Fast-track
- Status last verified
- Feb 2015
- First submitted
- 23 Jan 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fast-track Treatment for Prosthetic Joint Infection (PJI)
- ClinicalTrials.gov ID
- NCT02372435
- Acronym / sponsor ID
- Fast-track / ChariteU
- Conditions
- Hip Prosthetic Joint Infection, Knee Prosthetic Joint Infection, Shoulder Prosthetic Joint Infection
- Keywords
- PJI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 26 Feb 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short interval | Experimental | Procedure: Shortening of the interval of two-stage prosthesis exchangeRe-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm"). |
| Long interval | Active comparator | Procedure: Shortening of the interval of two-stage prosthesis exchangeRe-Implantation of the prosthesis after a Long interval of 6-10 weeks (standard surgical treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Shortening of the interval of two-stage prosthesis exchangeThe 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. | Procedure or surgery | Long interval, Short interval |
Primary outcome
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).
1 secondary outcome
Functional outcome
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
Related trials for Hip Prosthetic Joint Infection
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Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
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ROADMAP Clinical Trial
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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.
Andrej Trampuz, PD principal investigator
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Shortening of the interval of two-stage prosthesis exchange in people with Hip Prosthetic Joint Infection and Knee Prosthetic Joint Infection, run by Charite University, Berlin, Germany.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antje Spranger (+4930450652416, antje.spranger@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection outcome (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2015.