Total Shoulder ArthroplastyNCT02143245
Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
A study testing Synovial Biopsy and Open Tissue Biopsy in people with Total Shoulder Arthroplasty, run by Ottawa Hospital Research Institute at 4 sites in Canada.
Trial summary
The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Shoulder Arthroplasty
- What is being tested?
- Synovial Biopsy and Open Tissue Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesCanada
- Study dates
- Jun 2014to Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures
- Suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively
- Revision shoulder surgery for patients described in (1)
- Provide consent
Who cannot join
- signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
St. Joseph's Health Care London
London, Ontario, N6A 4V2
Sacré-Coeur Hospital of Montreal
Montreal, Quebec, H4J 1C5
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the investigators hope to avoid more invasive intervention if it is not needed. Some patients may appear to have an infection but once the biopsy is taken and the results are read, there may not be an infection and therefore no need for a revision surgery.
Read the detailed description
The primary research objective is to assess the diagnostic accuracy of percutaneous synovial biopsy for detection of implant-related intra-articular shoulder infections (IISI).
The secondary objectives are to document the frequency of pain associated with shoulder synovial biopsy and to determine the correlation and agreement of several indices of infection as a means of providing preliminary evidence toward a clinical decision rule to rule in or rule out the diagnosis of implant-related intra-articular shoulder infection.
The third objective is to determine the rates of (re)infection, functional outcomes, and quality of life, over a two year follow up period following revision surgery.
The fourth objective is to determine whether an association exists between the biopsy location within the joint and relative yield and positive culture rates.
The fifth objective is to identify, develop, and validate tissue-specific biomarkers for the detection of IISI.
It is our hypothesis that synovial biopsy is valid tool for use in the diagnosis of shoulder arthroplasty and fracture implant related infections.
- Conditions
- Total Shoulder Arthroplasty
- Being tested
- Synovial Biopsy, Open Tissue Biopsy
- Keywords
- Shoulder Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial BiopsyDiagnostic test
Synovial biopsy is a procedure using a guided needle, where 6 to 8 small tissue samples with be extracted from the shoulder using an x-ray guided needle.
Open Tissue BiopsyDiagnostic test
During the standard of care revision surgery, 6 to 8 small tissue samples will be taken in order to test for infection. This is standard of care treatment. As part of this study, an additional 1 to 2 samples of tissue would be taken in order to develop a test to determine more precisely what type of infection there may be.
| Study group | Role | What they receive |
|---|---|---|
| Revision Population | Other | The study population is both men and women who have had previous shoulder surgery with symptoms suggestive of deep infection. These include the presence of pain, stiffness, and radiologic signs of infection including implant lucencies or migration.
Patients in this population will undergo a synovial biopsy, in addition to undergoing an open tissue biopsy at the time of their procedure. Diagnostic accuracy will be compared, and all participants will be tracked over time. Receives: Diagnostic Test: Synovial Biopsy; Diagnostic Test: Open Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard)
To assess the diagnostic accuracy of percutaneous synovial biopsy (test procedure) for detection of implant-related intraarticular shoulder infections (IISI), in comparison to direct macroscopic synovial biopsy, from either arthroscopic or open procedures (the reference standard).
To address the primary objective, standard diagnostic accuracy statistics (sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio) will be derived, comparing lab results from percutaneous synovial biopsy specimen collection to those of the reference standard test (open/arthroscopic).
Measured: Pre-operatively.
Secondary outcomes (1)
Reported Pain
Using a visual analog scale, participants will rank their pain level 24-hours after the synovial biopsy. 0 indicating no pain, and 10 indicating the worst pain. A higher score indicates a worse outcome.
Measured: 24-hours after biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2022
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143245
- Sponsor's protocol ID
- 20140167-01H
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2014
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
- ClinicalTrials.gov ID
- NCT02143245
- Acronym / sponsor ID
- 20140167-01H
- Conditions
- Total Shoulder Arthroplasty
- Keywords
- Shoulder Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 May 2014 (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 the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the investigators hope to avoid more invasive intervention if it is not needed. Some patients may appear to have an infection but once the biopsy is taken and the results are read, there may not be an infection and therefore no need for a revision surgery.
Detailed description
The primary research objective is to assess the diagnostic accuracy of percutaneous synovial biopsy for detection of implant-related intra-articular shoulder infections (IISI).
The secondary objectives are to document the frequency of pain associated with shoulder synovial biopsy and to determine the correlation and agreement of several indices of infection as a means of providing preliminary evidence toward a clinical decision rule to rule in or rule out the diagnosis of implant-related intra-articular shoulder infection.
The third objective is to determine the rates of (re)infection, functional outcomes, and quality of life, over a two year follow up period following revision surgery.
The fourth objective is to determine whether an association exists between the biopsy location within the joint and relative yield and positive culture rates.
The fifth objective is to identify, develop, and validate tissue-specific biomarkers for the detection of IISI.
It is our hypothesis that synovial biopsy is valid tool for use in the diagnosis of shoulder arthroplasty and fracture implant related infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision Population | Other | Diagnostic Test: Synovial Biopsy, Diagnostic Test: Open Tissue BiopsyThe study population is both men and women who have had previous shoulder surgery with symptoms suggestive of deep infection. These include the presence of pain, stiffness, and radiologic signs of infection including implant lucencies or migration. Patients in this population will undergo a synovial biopsy, in addition to undergoing an open tissue biopsy at the time of their procedure. Diagnostic accuracy will be compared, and all participants will be tracked over time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures
- Suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively
- Revision shoulder surgery for patients described in (1)
- Provide consent
Key exclusion criteria (3 listed)
- signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
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 BiopsySynovial biopsy is a procedure using a guided needle, where 6 to 8 small tissue samples with be extracted from the shoulder using an x-ray guided needle. | Diagnostic test | Revision Population |
| Open Tissue BiopsyDuring the standard of care revision surgery, 6 to 8 small tissue samples will be taken in order to test for infection. This is standard of care treatment. As part of this study, an additional 1 to 2 samples of tissue would be taken in order to develop a test to determine more precisely what type of infection there may be. | Diagnostic test | Revision Population |
Primary outcome
Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard)
Time frame: Pre-operatively.
To assess the diagnostic accuracy of percutaneous synovial biopsy (test procedure) for detection of implant-related intraarticular shoulder infections (IISI), in comparison to direct macroscopic synovial biopsy, from either arthroscopic or open procedures (the reference standard). To address the primary objective, standard diagnostic accuracy statistics (sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio) will be derived, comparing lab results from percutaneous synovial biopsy specimen collection to those of the reference standard test (open/arthroscopic).
1 secondary outcome
Reported Pain
Time frame: 24-hours after biopsy.
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 30 Apr 2024.
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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.
Peter Lapner, MD principal investigator
The Ottawa Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synovial Biopsy and Open Tissue Biopsy in people with Total Shoulder Arthroplasty, run by Ottawa Hospital Research Institute at 4 sites in Canada.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard) (time frame: Pre-operatively.). 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 30 Apr 2024.