Prosthetic-joint InfectionSHIFTNCT05642013
SHort Interval Full Two-stage Implant Exchange
A study testing Early prosthesis reimplantation and Retrospective analysis of medical records in people with Prosthetic-joint Infection, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- Early prosthesis reimplantation and Retrospective analysis of medical records
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jan 2023to 23 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Prospective group:
- Patient over 18 years old
- Patient managed for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed / Or biological ≥ 2 samples positive for the same microorganism / And/ or 3000 leukocytes or > 80% of PNN on the synovial fluid / Or histological: visible microorganism, > or = 5 PNN on 5 HPN
- Patient with an indication for 2-stage surgery:
- A Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis / B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor
- Effective contraception during the research period for fertile women of childbearing age
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- Retrospective group :
- Patient managed before 31/12/2021 for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed Or biological ≥ 2 samples positive for the same microorganism And/ or 3000 leukocytes or > 80% of PNN on the synovial fluid Or histological: visible microorganism, > or = 5 PNN on 5 HPN
- Patient managed by 2 "long" stage surgery with reimplantation time > 6 weeks with an evolutionary follow-up of at least 15 months after the end of antibiotics
Who cannot join
- Prospective group :
- Indication for conservative treatment, 1-stage or 2 long stage surgery
- Reimplantation by another surgical approach requiring complete skin closure of the initial scar
- Other surgeries scheduled within 30 days of removal
- Participation in another interventional treatment study and/or in an exclusion period due to participation in another protocol
- Subject not affiliated with a social security plan or beneficiary of such a plan
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- Failure to obtain written informed consent
- Patient with a legal protection measure (guardianship, curatorship)
- Patient under justice safeguard
- Pregnant or breastfeeding woman
- Retrospective group :
- Refusal to participate
- Study exit criteria
- Bacteriological samples positive for fungi
- Infection not retained after analysis of samples (no sufficient clinical or biological criteria according to EBJIS definition)
- Withdrawal of consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34090
Nathalie PANSU, PH, 06 65 84 93 64 ext. + 33, n-pansu@chu-montpellier.fr
- Recruiting
CH de Sète - Hôpitaux du bassin de Thau
Sète, 34200
Flavien BOUCHET, Ph, 06 50 65 30 94 ext. +33, fbouchet@ch-bassindethau.fr
About this study
This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection.
This study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange.
The duration of the study is 42 months.
Read the detailed description
Prosthetic joint infection (PJI) is a rare but severe complication, with long and complex medico-surgical procedures ang high morbidity. Two-stage full implant exchange is commonly used for PJI, but the best time for prosthesis reimplantation remains unclear. Late reimplantation leads to prolonged immobilization, which can cause decubitus complications and altered joint functionnality.
The hypothesis is that reimplantation between 16 and 30 days after implants removal, earlier than suggested by some relatively old recommandations, associated with 12 weeks antibiotic therapy is a safe and efficient option, allowing shorter immobilization susceptible to improve joint functionnality.
The principal aim of this study is to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation.
50 patients with knee or hip PJI eligible for two-stage implant exchange will be prospectively included in two french centers.
Surgical procedure will be standardized, with prothesis reimplantation within 16 to 30 days after implants removal, associated with 12 weeks adaptated antibiotherapy according to french recommendations.
Patients will be compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange in these centers until december 2021 (retrospective group).
Follow up consists of 7 clinical evaluations, from inclusion until month15 after prosthesis removal.
- Conditions
- Prosthetic-joint Infection
- Being tested
- Early prosthesis reimplantation, Retrospective analysis of medical records
- Keywords
- prosthetic joint infection, knee, hip, two-stage exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early prosthesis reimplantationProcedure or surgery
Early prosthesis reimplantation, within 16 to 30 days after implants removal
Retrospective analysis of medical recordsOther
Analysis of 50 records of operated patients managed with classical two-stage implant exchange
| Study group | Role | What they receive |
|---|---|---|
| Prospective group | Experimental | 50 patients prospectively included with early prosthesis reimplantation Receives: Procedure: Early prosthesis reimplantation |
| Retrospective group | Other | Last 50 patients with hip or knee prosthetic-joint infection managed with classical two-stage implant exchange Receives: Other: Retrospective analysis of medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eligible patients included and benefiting from the standardized protocol without major deviations
Number of eligible patients having been included in the study having benefited from the standardized protocol without major deviations / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments
Measured: At 3 months follow-up
Secondary outcomes (10)
Rate of eligible patients included
Number of eligible patients included in the study / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments
Measured: At 3 months follow-up
Rate of clinical cure
Number of patients included without signs of infectious relapse to the same germ or persistence of the initial infection at M15 / number of patients included who benefited from the standardized protocol without major deviations., compared to clinical cure rate in retrospective group
Measured: At 15 months follow-up
Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15
Number of patients who presented a reinfection according to the EBJIS criteria with a germ different from the initial organism(s) during follow-up / number of patients included who benefited from the standardized protocol without major deviations, compared to reinfection rate in retrospective group
Measured: At 15 months follow-up
Length of stay
Cumulative length of stay in hospital (medicine or surgery wards) or in follow-up care compared to cumulative length of stay in retrospective group
Measured: At 15 months follow-up
Articular functionnality
Knee Society Score or Harris Hip Score
Measured: At 6 months follow-up
Articular functionnality
Knee Society Score or Harris Hip Score
Measured: At 15 months follow-up
Quality of life auto-evaluation score
EQ-5D-5L score (auto-questionnary)
Measured: At inclusion
Quality of life auto-evaluation score
EQ-5D-5L score (auto-questionnary)
Measured: At 3 months follow-up
Quality of life auto-evaluation score
EQ-5D-5L score (auto-questionnary)
Measured: At 15 months follow-up
Antibiotics tolerance
Evaluation of antibiotics tolerance by clinical +/- biological evaluation
Measured: From inclusion to 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start23 Jan 2023
- Primary completion23 Apr 2026 (estimated)
- Study completion23 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie PANSU, MD, Principal investigator, Infectious Diseases department, Montpellier university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642013
- Sponsor's protocol ID
- RECHMPL22_0231
- Acronym
- SHIFT
- Status last verified
- Aug 2024
- First submitted
- 29 Nov 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHort Interval Full Two-stage Implant Exchange
- ClinicalTrials.gov ID
- NCT05642013
- Acronym / sponsor ID
- SHIFT / RECHMPL22_0231
- Conditions
- Prosthetic-joint Infection
- Keywords
- prosthetic joint infection, knee, hip, two-stage exchange
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 23 Jul 2027 (estimated)
- First posted
- 8 Dec 2022 (actual)
- 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.
This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection.
This study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange.
The duration of the study is 42 months.
Detailed description
Prosthetic joint infection (PJI) is a rare but severe complication, with long and complex medico-surgical procedures ang high morbidity. Two-stage full implant exchange is commonly used for PJI, but the best time for prosthesis reimplantation remains unclear. Late reimplantation leads to prolonged immobilization, which can cause decubitus complications and altered joint functionnality.
The hypothesis is that reimplantation between 16 and 30 days after implants removal, earlier than suggested by some relatively old recommandations, associated with 12 weeks antibiotic therapy is a safe and efficient option, allowing shorter immobilization susceptible to improve joint functionnality.
The principal aim of this study is to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation.
50 patients with knee or hip PJI eligible for two-stage implant exchange will be prospectively included in two french centers.
Surgical procedure will be standardized, with prothesis reimplantation within 16 to 30 days after implants removal, associated with 12 weeks adaptated antibiotherapy according to french recommendations.
Patients will be compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange in these centers until december 2021 (retrospective group).
Follow up consists of 7 clinical evaluations, from inclusion until month15 after prosthesis removal.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group | Experimental | Procedure: Early prosthesis reimplantation50 patients prospectively included with early prosthesis reimplantation |
| Retrospective group | Other | Other: Retrospective analysis of medical recordsLast 50 patients with hip or knee prosthetic-joint infection managed with classical two-stage implant exchange |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient over 18 years old
- Patient managed for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed / Or biological ≥ 2 samples positive for the same microorganism / And/ or 3000 leukocytes or > 80% of PNN on the synovial fluid / Or histological: visible microorganism, > or = 5 PNN on 5 HPN
- Patient with an indication for 2-stage surgery:
- A Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis / B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor
- Effective contraception during the research period for fertile women of childbearing age
Key exclusion criteria (16 listed)
- Indication for conservative treatment, 1-stage or 2 long stage surgery
- Reimplantation by another surgical approach requiring complete skin closure of the initial scar
- Other surgeries scheduled within 30 days of removal
- Participation in another interventional treatment study and/or in an exclusion period due to participation in another protocol
- Subject not affiliated with a social security plan or beneficiary of such a plan
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 |
|---|---|---|
| Early prosthesis reimplantationEarly prosthesis reimplantation, within 16 to 30 days after implants removal | Procedure or surgery | Prospective group |
| Retrospective analysis of medical recordsAnalysis of 50 records of operated patients managed with classical two-stage implant exchange | Other | Retrospective group |
Primary outcome
Rate of eligible patients included and benefiting from the standardized protocol without major deviations
Time frame: At 3 months follow-up
Number of eligible patients having been included in the study having benefited from the standardized protocol without major deviations / number of eligible patients according to surgeons or doctors during consultations and hospitalization in orthopedic or infectious disease departments
10 secondary outcomes
Rate of eligible patients included
Time frame: At 3 months follow-up
Rate of clinical cure
Time frame: At 15 months follow-up
Rate of re-infection with a different microorganism (superinfection) during follow-up and up to M15
Time frame: At 15 months follow-up
Length of stay
Time frame: At 15 months follow-up
Articular functionnality
Time frame: At 6 months follow-up
Articular functionnality
Time frame: At 15 months follow-up
Quality of life auto-evaluation score
Time frame: At inclusion
Quality of life auto-evaluation score
Time frame: At 3 months follow-up
Quality of life auto-evaluation score
Time frame: At 15 months follow-up
Antibiotics tolerance
Time frame: From inclusion to 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
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oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
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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.
Nathalie PANSU, MD principal investigator
Infectious Diseases department, Montpellier university hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early prosthesis reimplantation and Retrospective analysis of medical records in people with Prosthetic-joint Infection, run by University Hospital, Montpellier at 2 sites in France.
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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie PANSU, MD (+33467339510, n-pansu@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of eligible patients included and benefiting from the standardized protocol without major deviations (time frame: At 3 months follow-up). 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 6 Aug 2024.