Arthropathy of HipNCT03365323
Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection
An observational study of Arthropathy of Hip and Arthropathy of Knee, run by Peking University People's Hospital.
Trial summary
This retrospective study aims to improve the diagnosis of PJI as well as to identify microorganisms causing periprosthetic joint infection (PJI) and the drug-resistant spectrum Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Arthropathy of Hip, Arthropathy of Knee
- What is being tested?
- Periprosthetic Joint Infection and Non-Periprosthetic Joint Infection
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Dec 2019
- Phase
- Observational
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution
Who may be able to join
- patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution
Who cannot join
- Patients who refused to join the trial group;
- Revision total hip/knee replacement for periprosthetic fracture;
- patients who missed some of important examination;
- Revision total hip/knee replacement for metal sensitivity;
- Revision total hip/knee replacement for the last period of second-stage revision;
- Patient who underwent revision with RA or other inflammatory disease.
Trial locations and contacts
No sites are listed yet.
About this study
This retrospective study aims to improve the diagnosis of PJI as well as to identify microorganisms causing periprosthetic joint infection (PJI) and the drug-resistant spectrum
Read the detailed description
160 patients who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution were recruited from August 2013 to August 2016. 80 patients meet the criteria of PJI from the muscle and skeletal muscle Association (MSIS) are divided to the infection group, another 80 patients are divided into the non-infection group.
Medical and demographic data were recorded. Collected lab examinations included blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), synovial leukocyte counts, Receiver Operating Characteristic Curve-Area Under Curve (ROC-AUC) analysis will be used to evaluate the specific and sensitivity of diagnosis index. Moreover,microorganisms isolated from periprosthetic tissues and articular fluid. Postoperatively, the prosthesis was sent for ultrasound sonication. The sonicate extraction, implant surrounding tissue and synovium were sent for microbiologic culture, and the implant-surrounding-tissue were also sent for pathological examination. The isolated strains and drug-resistance rate for each bacterium for different antibiotics were presented.
- Conditions
- Arthropathy of Hip, Arthropathy of Knee
- Being tested
- Periprosthetic Joint Infection, Non-Periprosthetic Joint Infection
- Keywords
- Periprosthetic Joint Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periprosthetic Joint InfectionOther
Periprosthetic Joint Infection is diagnosed according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
Non-Periprosthetic Joint InfectionOther
PJI can not be diagnosed for the lack of clinical evidence according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
| Study group | Role | What they receive |
|---|---|---|
| infectious group | Patients who met the criteria according of Periprosthetic Joint Infection were identified as the infectious group. Receives: Other: Periprosthetic Joint Infection | |
| non-infectious group | Patients who didn't meet the criteria according of Periprosthetic Joint Infection were identified as the non-periprosthetic joint infection group. Receives: Other: Non-Periprosthetic Joint Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the specific and sensitivity of CRP
To test the specifity and sensitivity of CRP
Measured: within 4 weeks before the operation
Evaluation the specific and sensitivity of ESR
To test the specifity and sensitivity of ESR
Measured: within 4 weeks before the operation
Evaluation the specific and sensitivity of synovial leukocyte counts
To test the specifity and sensitivity of synovial leukocyte counts
Measured: within 4 weeks before the operation
Secondary outcomes (2)
Microorganisms identification and the
Identify microorganisms causing periprosthetic joint infection (PJI) as well as the drug-resistant spectrum.
Measured: within 4 weeks before the operation
Drug-resistant spectrum.
Identify the drug-resistant spectrum of the microorganisms.
Measured: within 4 weeks before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Jianhao, Peking University People's Hospital
- Investigators
- Jianhao Lin, Principal investigator, arthritis and clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365323
- Sponsor's protocol ID
- PKUPHACRC3
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03365323
- Acronym / sponsor ID
- PKUPHACRC3
- Conditions
- Arthropathy of Hip, Arthropathy of Knee
- Keywords
- Periprosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 Dec 2017 (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 retrospective study aims to improve the diagnosis of PJI as well as to identify microorganisms causing periprosthetic joint infection (PJI) and the drug-resistant spectrum
Detailed description
160 patients who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution were recruited from August 2013 to August 2016. 80 patients meet the criteria of PJI from the muscle and skeletal muscle Association (MSIS) are divided to the infection group, another 80 patients are divided into the non-infection group.
Medical and demographic data were recorded. Collected lab examinations included blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), synovial leukocyte counts, Receiver Operating Characteristic Curve-Area Under Curve (ROC-AUC) analysis will be used to evaluate the specific and sensitivity of diagnosis index. Moreover,microorganisms isolated from periprosthetic tissues and articular fluid. Postoperatively, the prosthesis was sent for ultrasound sonication. The sonicate extraction, implant surrounding tissue and synovium were sent for microbiologic culture, and the implant-surrounding-tissue were also sent for pathological examination. The isolated strains and drug-resistance rate for each bacterium for different antibiotics were presented.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infectious group | – | Other: Periprosthetic Joint InfectionPatients who met the criteria according of Periprosthetic Joint Infection were identified as the infectious group. |
| non-infectious group | – | Other: Non-Periprosthetic Joint InfectionPatients who didn't meet the criteria according of Periprosthetic Joint Infection were identified as the non-periprosthetic joint infection group. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution
Key inclusion criteria (1 listed)
- patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution
Key exclusion criteria (6 listed)
- Patients who refused to join the trial group;
- Revision total hip/knee replacement for periprosthetic fracture;
- patients who missed some of important examination;
- Revision total hip/knee replacement for metal sensitivity;
- Revision total hip/knee replacement for the last period of second-stage revision;
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 |
|---|---|---|
| Periprosthetic Joint InfectionPeriprosthetic Joint Infection is diagnosed according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society. | Other | infectious group |
| Non-Periprosthetic Joint InfectionPJI can not be diagnosed for the lack of clinical evidence according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society. | Other | non-infectious group |
Primary outcome
Evaluation the specific and sensitivity of CRP
Time frame: within 4 weeks before the operation
To test the specifity and sensitivity of CRP
Evaluation the specific and sensitivity of ESR
Time frame: within 4 weeks before the operation
To test the specifity and sensitivity of ESR
Evaluation the specific and sensitivity of synovial leukocyte counts
Time frame: within 4 weeks before the operation
To test the specifity and sensitivity of synovial leukocyte counts
2 secondary outcomes
Microorganisms identification and the
Time frame: within 4 weeks before the operation
Drug-resistant spectrum.
Time frame: within 4 weeks before the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Jianhao Lin principal investigator
arthritis and clinic and research center
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Hip and Arthropathy of Knee, run by Peking University People's Hospital.
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 1 inclusion and 6 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 7 Dec 2017. 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 Zhanglai Li (+86 17801099200, 847869561@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the specific and sensitivity of CRP (time frame: within 4 weeks before the operation). The study lists 3 primary outcomes in all. 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 7 Dec 2017.