Infection of Total Knee Joint ProsthesisCOSPINCT02594930
Comparison of Two Different Techniques of Synovial Biopsy and Resistances of Cutaneous Smears in Suspected PPI
A study testing synovial biopsy of total knee arthroplasty in people with Infection of Total Knee Joint Prosthesis, run by Technical University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection of Total Knee Joint Prosthesis
- What is being tested?
- synovial biopsy of total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Nov 2017
- 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
- Chronic painful knee prosthesis planned for synovial biopsy to detect infection
- Culture-negative joint aspiration
Who cannot join
- Co-morbidities: Tumour disease, immune suppression
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, Bavaria, 81675
Norbert Harrasser, DR., 00498941405229, norbert.harrasser@gmx.net
Ingo Banke, Dr., 00498941405284, ingo@banke.eu
About this study
Official title: Comparison of Directed Versus Undirected Synovial Biopsy in Culture-negative Periprosthetic Joint Infections (With Preoperative Smears From the Skin) of the Knee and Evaluation of Outcome After Revision Joint Arthroplasty
The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.
Read the detailed description
Successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. The value of a preoperative biopsy remains controversial. We compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.
- Conditions
- Infection of Total Knee Joint Prosthesis
- Being tested
- synovial biopsy of total knee arthroplasty
- Keywords
- synovial biopsy, knee arthroplasty, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synovial biopsy of total knee arthroplastyProcedure or surgery
synovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results
| Study group | Role | What they receive |
|---|---|---|
| undirected and directed biopsy | Experimental | Via an antero-lateral incision of the knee samples are taken without visual control; Afterwards an arthroscope is inserted and samples are taken from 5 defined regions of the knee (suprapatellar pouch, medial and lateral gutter, notch, Hoffa's fat pad) Receives: Procedure: synovial biopsy of total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of microbiological and histological results of undirected and directed synovial biopsies
5 microbiological samples and 1 histological sample are taken form the knee undirected via an antero-lateral approach. Afterwards the same sample numbers are taken under arthroscopic view. Correlation of results between those two methods are investigated. If infection is detected two-stage exchange of prosthesis is performed. At this surgery samples from synovia and the implant-bone interface are again taken and again investigated for correlation.
Measured: within the first 14 days after surgery
Secondary outcomes (1)
Correlation of microbiological results from synovial biopsy with intraoperative findings at revision
Measured: within the first 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection of Total Knee Joint ProsthesisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrasser, Technical University of Munich
- Investigators
- Ruediger Eisenhart-Rothe, Prof., Study chair, Klinikum rechts der Isar, TU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594930
- Sponsor's protocol ID
- AAA-11/145
- Acronym
- COSPI
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Scheele C, Krauel I, Pohlig F, Muehlhofer H, Gerdesmeyer L, Lasic I, Prodinger PM, Banke I, von Eisenhart-Rothe R, Harrasser N. Guided and Unguided Biopsy in the Diagnostic of Periprosthetic Infections of the Knee - Evaluation of an Evidence-based Algorithm. Z Orthop Unfall. 2019 Dec;157(6):684-694. doi: 10.1055/a-1034-0923. Epub 2019 Oct 28. English, German.
PubMed 31658475
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Directed Versus Undirected Synovial Biopsy in Culture-negative Periprosthetic Joint Infections (With Preoperative Smears From the Skin) of the Knee and Evaluation of Outcome After Revision Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT02594930
- Acronym / sponsor ID
- COSPI / AAA-11/145
- Conditions
- Infection of Total Knee Joint Prosthesis
- Keywords
- synovial biopsy, knee arthroplasty, infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 3 Nov 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.
The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.
Detailed description
Successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. The value of a preoperative biopsy remains controversial. We compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| undirected and directed biopsy | Experimental | Procedure: synovial biopsy of total knee arthroplastyVia an antero-lateral incision of the knee samples are taken without visual control; Afterwards an arthroscope is inserted and samples are taken from 5 defined regions of the knee (suprapatellar pouch, medial and lateral gutter, notch, Hoffa's fat pad) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic painful knee prosthesis planned for synovial biopsy to detect infection
- Culture-negative joint aspiration
Key exclusion criteria (1 listed)
- Co-morbidities: Tumour disease, immune suppression
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 |
|---|---|---|
| synovial biopsy of total knee arthroplastysynovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results | Procedure or surgery | undirected and directed biopsy |
Primary outcome
Correlation of microbiological and histological results of undirected and directed synovial biopsies
Time frame: within the first 14 days after surgery
5 microbiological samples and 1 histological sample are taken form the knee undirected via an antero-lateral approach. Afterwards the same sample numbers are taken under arthroscopic view. Correlation of results between those two methods are investigated. If infection is detected two-stage exchange of prosthesis is performed. At this surgery samples from synovia and the implant-bone interface are again taken and again investigated for correlation.
1 secondary outcome
Correlation of microbiological results from synovial biopsy with intraoperative findings at revision
Time frame: within the first 14 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Derived from this study: PubMed 31658475Scheele C, Krauel I, Pohlig F, Muehlhofer H, Gerdesmeyer L, Lasic I, Prodinger PM, Banke I, von Eisenhart-Rothe R, Harrasser N. Guided and Unguided Biopsy in the Diagnostic of Periprosthetic Infections of the Knee - Evaluation of an Evidence-based Algorithm. Z Orthop Unfall. 2019 Dec;157(6):684-694. doi: 10.1055/a-1034-0923. Epub 2019 Oct 28. English, German.
- 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.
Ruediger Eisenhart-Rothe, Prof. study chair
Klinikum rechts der Isar, TU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synovial biopsy of total knee arthroplasty in people with Infection of Total Knee Joint Prosthesis, run by Technical University of Munich at 1 site in 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 2 inclusion and 1 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 19 Oct 2016. 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 Germany. 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 Norbert Harrasser, Dr. (00498941405229, norbert.harrasser@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of microbiological and histological results of undirected and directed synovial biopsies (time frame: within the first 14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594930, which also lists 1 linked publication.
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 19 Oct 2016.