Chronically Infected Total Hip of Knee ProsthesisIPRONCT02651961
Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
A study testing Exchange of total hip or knee arthroplasty on same time and Exchange of total hip or knee arthroplasty in two time in people with Chronically Infected Total Hip of Knee Prosthesis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronically Infected Total Hip of Knee Prosthesis
- What is being tested?
- Exchange of total hip or knee arthroplasty on same time and Exchange of total hip or knee arthroplasty in two time
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2018to 2 Oct 2022
- 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
- Age ≥ 18 years
- Chronically infected total hip or knee arthroplasty requiring implant exchange
- Affiliation to a social security system
- Signed informed consent
- Effective contraception during all study
Who cannot join
- Repeat exchange after failure of a prior treatment for infection
- Multiple implant infection
- Infection due to mycobacteria or fungus
- Pregnancy / Breast feeding
- Patient under judicial protection
- Impossibility to give informed consent for any reason
- Participation to another study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Jean-Yves JENNY, MD, 0388552456, jean-yves.jenny@chru-strasbourg.fr
About this study
Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.
Read the detailed description
The primary criterion will be the cost-utility ratio (ICER) at 12 months follow-up.
The secondary criteria will be:
- quality of life;
- pain;
- persistence or recurrence of infection;
- occurrence of complications ;
- necessity for reoperation.
- Being tested
- Exchange of total hip or knee arthroplasty on same time, Exchange of total hip or knee arthroplasty in two time
- Keywords
- Total hip prosthesis, Total knee prosthesis, Chronic infection, One stage exchange, Two stage exchange, Cost-effectiveness
- Medical subject headings
- Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exchange of total hip or knee arthroplasty on same timeProcedure or surgery
Removal of the index implants, extensive debridement, reimplantation of a new prosthesis
Exchange of total hip or knee arthroplasty in two timeProcedure or surgery
Removal of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time
| Study group | Role | What they receive |
|---|---|---|
| One stage exchange | Active comparator | One stage exchange of the chronically infected implant Receives: Procedure: Exchange of total hip or knee arthroplasty on same time |
| Two stage exchange | Active comparator | Two stage exchange of the chronically infected implant Receives: Procedure: Exchange of total hip or knee arthroplasty in two time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility ratio (ICER)
Measured: 12 months post-operative
Secondary outcomes (11)
Quality of life : EQ-5D questionnaire
Patient-reported generic (EQ-5D) outcomes questionnaire
Measured: 12 months post-operative
Pain : VAS score
Patient-reported pain score with visual analogic scale
Measured: 12 months post-operative
Number of Persistence or recurrence of infection for all participants
Measured: 24 months post-operative
Occurrence of complications
Measured: 24 months post-operative
number of Necessity of reoperation for all patient
necessity of reoperation will be assessed with clinical examination
Measured: 12 months post-operative
Operating time of all surgical procedures
operating time is from time of entrance in the operating room to time of the end of intervention (hh:mm)
Measured: procedure
Duration of whole treatment
Measured: 12 months post-operative
Cost of complication treatment
Measured: 12 months post-operative
Cost of repeat surgery
Measured: 12 months post-operative
Quality of life : Oxford hip or knee questionnaires
Patient-reported specific (Oxford) outcomes questionnaire
Measured: 12 months post-operative
cost of whole treatment
Measured: 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start3 May 2018
- Primary completion2 Oct 2022 (estimated)
- Study completion2 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronically Infected Total Hip of Knee ProsthesisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves JENNY, PH, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651961
- Sponsor's protocol ID
- 6262
- Acronym
- IPRO
- Status last verified
- May 2018
- First submitted
- 25 Nov 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
- ClinicalTrials.gov ID
- NCT02651961
- Acronym / sponsor ID
- IPRO / 6262
- Keywords
- Total hip prosthesis, Total knee prosthesis, Chronic infection, One stage exchange, Two stage exchange, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 2 Oct 2022 (estimated)
- Study completion
- 2 Oct 2022 (estimated)
- First posted
- 11 Jan 2016 (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.
Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.
Detailed description
The primary criterion will be the cost-utility ratio (ICER) at 12 months follow-up.
The secondary criteria will be:
- quality of life;
- pain;
- persistence or recurrence of infection;
- occurrence of complications ;
- necessity for reoperation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One stage exchange | Active comparator | Procedure: Exchange of total hip or knee arthroplasty on same timeOne stage exchange of the chronically infected implant |
| Two stage exchange | Active comparator | Procedure: Exchange of total hip or knee arthroplasty in two timeTwo stage exchange of the chronically infected implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Chronically infected total hip or knee arthroplasty requiring implant exchange
- Affiliation to a social security system
- Signed informed consent
- Effective contraception during all study
Key exclusion criteria (7 listed)
- Repeat exchange after failure of a prior treatment for infection
- Multiple implant infection
- Infection due to mycobacteria or fungus
- Pregnancy / Breast feeding
- Patient under judicial protection
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 |
|---|---|---|
| Exchange of total hip or knee arthroplasty on same timeRemoval of the index implants, extensive debridement, reimplantation of a new prosthesis | Procedure or surgery | One stage exchange |
| Exchange of total hip or knee arthroplasty in two timeRemoval of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time | Procedure or surgery | Two stage exchange |
Primary outcome
Cost-utility ratio (ICER)
Time frame: 12 months post-operative
11 secondary outcomes
Quality of life : EQ-5D questionnaire
Time frame: 12 months post-operative
Pain : VAS score
Time frame: 12 months post-operative
Number of Persistence or recurrence of infection for all participants
Time frame: 24 months post-operative
Occurrence of complications
Time frame: 24 months post-operative
number of Necessity of reoperation for all patient
Time frame: 12 months post-operative
Operating time of all surgical procedures
Time frame: procedure
Duration of whole treatment
Time frame: 12 months post-operative
Cost of complication treatment
Time frame: 12 months post-operative
Cost of repeat surgery
Time frame: 12 months post-operative
Quality of life : Oxford hip or knee questionnaires
Time frame: 12 months post-operative
cost of whole treatment
Time frame: 12 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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.
Jean-Yves JENNY, PH principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exchange of total hip or knee arthroplasty on same time and Exchange of total hip or knee arthroplasty in two time in people with Chronically Infected Total Hip of Knee Prosthesis, run by University Hospital, Strasbourg, France at 1 site 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 5 inclusion and 7 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène SOAVELO (+33388116559, helene.soavelo@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility ratio (ICER) (time frame: 12 months post-operative). 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 22 May 2018.