Orthopaedic Trauma InfectionsNCT03126448
BBOT: Bacterial Burden in Ortho Trauma Procedures
A study testing Highly Sensitive Assays in people with Orthopaedic Trauma Infections, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this research project is to improve understanding of the potential role of highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the current standard of care, microbiologic culture (growing bacteria from tissue specimens in the laboratory). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopaedic Trauma Infections
- What is being tested?
- Highly Sensitive Assays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2015to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Closed fracture undergoing open reduction internal fixation, intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation.
- Plate and screw removal without clinical evidence of infection
- Index procedure for fracture nonunion
Who cannot join
- Index fracture surgery for an open fracture or intramedullary nailing with fracture site not accessible
- Hardware removal if fracture not already healed
- Index nonunion surgery being bone grafting of a 'critical' defect
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201
About this study
Official title: Prospective Evaluation of Bacterial Burden in Orthopaedic Trauma Procedures Using Highly Sensitive Assays
The purpose of this research project is to improve understanding of the potential role of highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the current standard of care, microbiologic culture (growing bacteria from tissue specimens in the laboratory).
In order to understand the validity of the highly sensitive tests, parameters of the test in different groups of patients must be established. This study is examining how two highly sensitive tests compare to each other and to the standard of care (microbiologic culture) in three groups of patients.
Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary nailing fixation where the fracture site is accessible, or staged treatment of a broken bones initially treated by joint spanning external fixation device. Group 2 will include patients having a plate and screws removed without clinical evidence of infection. Group 3 will be patients undergoing an initial procedure for fracture nonunion.
Read the detailed description
Infected, broken bones that do not heal are a difficult clinical problem that significantly affect patient quality of life. Current methodology for detecting bacteria (growth in laboratory cultures) is inadequate to detect infections caused by bacteria existing in a biofilm, which is the layer of "slime" found in the presence of foreign bodies (eg, implanted metal devices to fix broken bones). Advances in molecular biology have allowed development of highly sensitive tests to detect bacteria in the biofilm state. However, the limited prior research has not included control groups or compared the performance of different highly sensitive tests. To address these limitations and further define the role of highly sensitive bacterial tests in clinical practice, the investigators hypothesize that there will be increasing bacterial burden when comparing clean broken bone surgery (1st surgery) to implanted metal device removal (2nd surgery, bone healed) to index nonunion surgery (subsequent surgery, bone not healed) as measured by percentage of cases being positive for bacteria using highly sensitive bacterial tests. Further, the highly sensitive bacterial tests (Illumina MiSeq system and Ibis T5000 biosensor) will have similar ability to quantify the number of bacteria and differentiate bacterial species. Eligible patients will consist of three groups. Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary nailing fixation where the fracture site is accessible, or staged treatment of a broken bones initially treated by joint spanning external fixation device. Group 2 will include patients having a plate and screws removed without clinical evidence of infection. Group 3 will be patients undergoing an initial procedure for fracture nonunion. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive tests. The tissue samples taken will be tissue normally removed and discarded in the course of these particular procedures. The rates of positivity for culture and the highly sensitive tests will be compared amongst the three groups. Investigators will also compare bacterial count and the distribution of bacterial species found using the two highly sensitive tests. These data will then undergo statistical analysis against clinical data gathered from review of the patients' charts. The overall project goal is to establish the clinical relevance of highly sensitive bacterial tests in diagnosing infected nonunions. The ability to more accurately identify patients with infection may lead to a change in clinical decision making with respect to surgical procedure or antibiotic treatment. This project will develop an improved understanding of the potential role of highly sensitive bacterial tests in diagnosing infected nonunions compared to the current standard of care, which is growing bacteria in the laboratory under artificial conditions.
- Conditions
- Orthopaedic Trauma Infections
- Being tested
- Highly Sensitive Assays
- Keywords
- Infection, Nonunion, Fracture healing
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly Sensitive AssaysDiagnostic test
Also called Ibis T5000 biosensor, Illumina MiSeq system
Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Closed Index Fractures | Other | Group 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays. Receives: Diagnostic Test: Highly Sensitive Assays |
| Group 2: Hardware Removal from Healed Fractures | Other | Group 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays. Receives: Diagnostic Test: Highly Sensitive Assays |
| Group 3: Index Treatment of Fracture Nonunions | Other | Group 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays. Receives: Diagnostic Test: Highly Sensitive Assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays
The objective of this research is to see if highly sensitive bacterial assays are useful for determining whether fracture nonunions are infected
Measured: Study surgery to 6-month clinical follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start21 Dec 2015
- Primary completion31 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Orthopaedic Trauma InfectionsStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert O'Toole, University of Maryland, Baltimore
- Investigators
- Robert V O'Toole, MD, Principal investigator, University of Maryland, College ParkMark Shirtliff, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126448
- Sponsor's protocol ID
- HP-00066769
- Status last verified
- Apr 2020
- First submitted
- 18 Apr 2017
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Palmer MP, Altman DT, Altman GT, Sewecke JJ, Ehrlich GD, Hu FZ, Nistico L, Melton-Kreft R, Gause TM 3rd, Costerton JW. Can we trust intraoperative culture results in nonunions? J Orthop Trauma. 2014 Jul;28(7):384-90. doi: 10.1097/BOT.0000000000000043.
PubMed 24343249Stucken C, Olszewski DC, Creevy WR, Murakami AM, Tornetta P. Preoperative diagnosis of infection in patients with nonunions. J Bone Joint Surg Am. 2013 Aug 7;95(15):1409-12. doi: 10.2106/JBJS.L.01034.
PubMed 23925746Bose D, Kugan R, Stubbs D, McNally M. Management of infected nonunion of the long bones by a multidisciplinary team. Bone Joint J. 2015 Jun;97-B(6):814-7. doi: 10.1302/0301-620X.97B6.33276.
PubMed 26033062Olszewski D, Streubel PN, Stucken C, Ricci WM, Hoffmann MF, Jones CB, Sietsema DL, Tornetta P 3rd. Fate of Patients With a "Surprise" Positive Culture After Nonunion Surgery. J Orthop Trauma. 2016 Jan;30(1):e19-23. doi: 10.1097/BOT.0000000000000417.
PubMed 26270457Schottel PC, O'Connor DP, Brinker MR. Time Trade-Off as a Measure of Health-Related Quality of Life: Long Bone Nonunions Have a Devastating Impact. J Bone Joint Surg Am. 2015 Sep 2;97(17):1406-10. doi: 10.2106/JBJS.N.01090.
PubMed 26333735Brinker MR, Hanus BD, Sen M, O'Connor DP. The devastating effects of tibial nonunion on health-related quality of life. J Bone Joint Surg Am. 2013 Dec 18;95(24):2170-6. doi: 10.2106/JBJS.L.00803.
PubMed 24352770Hannigan GD, Hodkinson BP, McGinnis K, Tyldsley AS, Anari JB, Horan AD, Grice EA, Mehta S. Culture-independent pilot study of microbiota colonizing open fractures and association with severity, mechanism, location, and complication from presentation to early outpatient follow-up. J Orthop Res. 2014 Apr;32(4):597-605. doi: 10.1002/jor.22578. Epub 2014 Jan 3.
PubMed 24395335Moussa FW, Anglen JO, Gehrke JC, Christensen G, Simpson WA. The significance of positive cultures from orthopedic fixation devices in the absence of clinical infection. Am J Orthop (Belle Mead NJ). 1997 Sep;26(9):617-20.
PubMed 9316724Dobbins JJ, Seligson D, Raff MJ. Bacterial colonization of orthopedic fixation devices in the absence of clinical infection. J Infect Dis. 1988 Jul;158(1):203-5. doi: 10.1093/infdis/158.1.203. No abstract available.
PubMed 3392414Jacovides CL, Kreft R, Adeli B, Hozack B, Ehrlich GD, Parvizi J. Successful identification of pathogens by polymerase chain reaction (PCR)-based electron spray ionization time-of-flight mass spectrometry (ESI-TOF-MS) in culture-negative periprosthetic joint infection. J Bone Joint Surg Am. 2012 Dec 19;94(24):2247-54. doi: 10.2106/JBJS.L.00210.
PubMed 23318615Struijs PA, Poolman RW, Bhandari M. Infected nonunion of the long bones. J Orthop Trauma. 2007 Aug;21(7):507-11. doi: 10.1097/BOT.0b013e31812e5578.
PubMed 17762489Motsitsi NS. Management of infected nonunion of long bones: the last decade (1996-2006). Injury. 2008 Feb;39(2):155-60. doi: 10.1016/j.injury.2007.08.032. Epub 2008 Jan 29.
PubMed 18234202Firoozabadi R, Alton T, Wenke J. Novel Strategies for the Diagnosis of Posttraumatic Infections in Orthopaedic Trauma Patients. J Am Acad Orthop Surg. 2015 Jul;23(7):443-51. doi: 10.5435/JAAOS-D-14-00174. Epub 2015 Jun 3.
PubMed 26040954Costerton JW, Post JC, Ehrlich GD, Hu FZ, Kreft R, Nistico L, Kathju S, Stoodley P, Hall-Stoodley L, Maale G, James G, Sotereanos N, DeMeo P. New methods for the detection of orthopedic and other biofilm infections. FEMS Immunol Med Microbiol. 2011 Mar;61(2):133-40. doi: 10.1111/j.1574-695X.2010.00766.x. Epub 2011 Jan 18.
PubMed 21204998Costerton JW. Biofilm theory can guide the treatment of device-related orthopaedic infections. Clin Orthop Relat Res. 2005 Aug;(437):7-11. doi: 10.1097/00003086-200508000-00003.
PubMed 16056019
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Bacterial Burden in Orthopaedic Trauma Procedures Using Highly Sensitive Assays
- ClinicalTrials.gov ID
- NCT03126448
- Acronym / sponsor ID
- HP-00066769
- Conditions
- Orthopaedic Trauma Infections
- Keywords
- Infection, Nonunion, Fracture healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 28 Apr 2020
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 research project is to improve understanding of the potential role of highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the current standard of care, microbiologic culture (growing bacteria from tissue specimens in the laboratory).
In order to understand the validity of the highly sensitive tests, parameters of the test in different groups of patients must be established. This study is examining how two highly sensitive tests compare to each other and to the standard of care (microbiologic culture) in three groups of patients.
Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary nailing fixation where the fracture site is accessible, or staged treatment of a broken bones initially treated by joint spanning external fixation device. Group 2 will include patients having a plate and screws removed without clinical evidence of infection. Group 3 will be patients undergoing an initial procedure for fracture nonunion.
Detailed description
Infected, broken bones that do not heal are a difficult clinical problem that significantly affect patient quality of life. Current methodology for detecting bacteria (growth in laboratory cultures) is inadequate to detect infections caused by bacteria existing in a biofilm, which is the layer of "slime" found in the presence of foreign bodies (eg, implanted metal devices to fix broken bones). Advances in molecular biology have allowed development of highly sensitive tests to detect bacteria in the biofilm state. However, the limited prior research has not included control groups or compared the performance of different highly sensitive tests. To address these limitations and further define the role of highly sensitive bacterial tests in clinical practice, the investigators hypothesize that there will be increasing bacterial burden when comparing clean broken bone surgery (1st surgery) to implanted metal device removal (2nd surgery, bone healed) to index nonunion surgery (subsequent surgery, bone not healed) as measured by percentage of cases being positive for bacteria using highly sensitive bacterial tests. Further, the highly sensitive bacterial tests (Illumina MiSeq system and Ibis T5000 biosensor) will have similar ability to quantify the number of bacteria and differentiate bacterial species. Eligible patients will consist of three groups. Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary nailing fixation where the fracture site is accessible, or staged treatment of a broken bones initially treated by joint spanning external fixation device. Group 2 will include patients having a plate and screws removed without clinical evidence of infection. Group 3 will be patients undergoing an initial procedure for fracture nonunion. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive tests. The tissue samples taken will be tissue normally removed and discarded in the course of these particular procedures. The rates of positivity for culture and the highly sensitive tests will be compared amongst the three groups. Investigators will also compare bacterial count and the distribution of bacterial species found using the two highly sensitive tests. These data will then undergo statistical analysis against clinical data gathered from review of the patients' charts. The overall project goal is to establish the clinical relevance of highly sensitive bacterial tests in diagnosing infected nonunions. The ability to more accurately identify patients with infection may lead to a change in clinical decision making with respect to surgical procedure or antibiotic treatment. This project will develop an improved understanding of the potential role of highly sensitive bacterial tests in diagnosing infected nonunions compared to the current standard of care, which is growing bacteria in the laboratory under artificial conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Closed Index Fractures | Other | Diagnostic Test: Highly Sensitive AssaysGroup 1 is clean, closed fractures undergoing index open reduction internal fixation (ORIF), intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays. |
| Group 2: Hardware Removal from Healed Fractures | Other | Diagnostic Test: Highly Sensitive AssaysGroup 2 will include patients having a plate removed from a healed fracture without clinical evidence of infection and excluding history of open fracture. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays. |
| Group 3: Index Treatment of Fracture Nonunions | Other | Diagnostic Test: Highly Sensitive AssaysGroup 3 will be patients that are undergoing an index procedure for fracture nonunion at a site where prior surgery has been undertaken for the fracture. Exclusions include bone grafting of 'critical' defects, active clinical infection, or < 3 months from index fracture fixation. Tissue obtained at the time of surgery will be sent to the research laboratory for culture and performance of the two highly sensitive assays. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Closed fracture undergoing open reduction internal fixation, intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation.
- Plate and screw removal without clinical evidence of infection
- Index procedure for fracture nonunion
Key exclusion criteria (4 listed)
- Index fracture surgery for an open fracture or intramedullary nailing with fracture site not accessible
- Hardware removal if fracture not already healed
- Index nonunion surgery being bone grafting of a 'critical' defect
- Pregnant females
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 |
|---|---|---|
| Highly Sensitive AssaysAlso: Ibis T5000 biosensor, Illumina MiSeq systemTissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results. | Diagnostic test | Group 1: Closed Index Fractures, Group 2: Hardware Removal from Healed Fractures, Group 3: Index Treatment of Fracture Nonunions |
Primary outcome
Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays
Time frame: Study surgery to 6-month clinical follow-up
The objective of this research is to see if highly sensitive bacterial assays are useful for determining whether fracture nonunions are infected
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24343249Palmer MP, Altman DT, Altman GT, Sewecke JJ, Ehrlich GD, Hu FZ, Nistico L, Melton-Kreft R, Gause TM 3rd, Costerton JW. Can we trust intraoperative culture results in nonunions? J Orthop Trauma. 2014 Jul;28(7):384-90. doi: 10.1097/BOT.0000000000000043.
- Background: PubMed 23925746Stucken C, Olszewski DC, Creevy WR, Murakami AM, Tornetta P. Preoperative diagnosis of infection in patients with nonunions. J Bone Joint Surg Am. 2013 Aug 7;95(15):1409-12. doi: 10.2106/JBJS.L.01034.
- Background: PubMed 26033062Bose D, Kugan R, Stubbs D, McNally M. Management of infected nonunion of the long bones by a multidisciplinary team. Bone Joint J. 2015 Jun;97-B(6):814-7. doi: 10.1302/0301-620X.97B6.33276.
- Background: PubMed 26270457Olszewski D, Streubel PN, Stucken C, Ricci WM, Hoffmann MF, Jones CB, Sietsema DL, Tornetta P 3rd. Fate of Patients With a "Surprise" Positive Culture After Nonunion Surgery. J Orthop Trauma. 2016 Jan;30(1):e19-23. doi: 10.1097/BOT.0000000000000417.
- Background: PubMed 26333735Schottel PC, O'Connor DP, Brinker MR. Time Trade-Off as a Measure of Health-Related Quality of Life: Long Bone Nonunions Have a Devastating Impact. J Bone Joint Surg Am. 2015 Sep 2;97(17):1406-10. doi: 10.2106/JBJS.N.01090.
- Background: PubMed 24352770Brinker MR, Hanus BD, Sen M, O'Connor DP. The devastating effects of tibial nonunion on health-related quality of life. J Bone Joint Surg Am. 2013 Dec 18;95(24):2170-6. doi: 10.2106/JBJS.L.00803.
- Background: PubMed 24395335Hannigan GD, Hodkinson BP, McGinnis K, Tyldsley AS, Anari JB, Horan AD, Grice EA, Mehta S. Culture-independent pilot study of microbiota colonizing open fractures and association with severity, mechanism, location, and complication from presentation to early outpatient follow-up. J Orthop Res. 2014 Apr;32(4):597-605. doi: 10.1002/jor.22578. Epub 2014 Jan 3.
- Background: PubMed 9316724Moussa FW, Anglen JO, Gehrke JC, Christensen G, Simpson WA. The significance of positive cultures from orthopedic fixation devices in the absence of clinical infection. Am J Orthop (Belle Mead NJ). 1997 Sep;26(9):617-20.
- Background: PubMed 3392414Dobbins JJ, Seligson D, Raff MJ. Bacterial colonization of orthopedic fixation devices in the absence of clinical infection. J Infect Dis. 1988 Jul;158(1):203-5. doi: 10.1093/infdis/158.1.203. No abstract available.
- Background: PubMed 23318615Jacovides CL, Kreft R, Adeli B, Hozack B, Ehrlich GD, Parvizi J. Successful identification of pathogens by polymerase chain reaction (PCR)-based electron spray ionization time-of-flight mass spectrometry (ESI-TOF-MS) in culture-negative periprosthetic joint infection. J Bone Joint Surg Am. 2012 Dec 19;94(24):2247-54. doi: 10.2106/JBJS.L.00210.
- Background: PubMed 17762489Struijs PA, Poolman RW, Bhandari M. Infected nonunion of the long bones. J Orthop Trauma. 2007 Aug;21(7):507-11. doi: 10.1097/BOT.0b013e31812e5578.
- Background: PubMed 18234202Motsitsi NS. Management of infected nonunion of long bones: the last decade (1996-2006). Injury. 2008 Feb;39(2):155-60. doi: 10.1016/j.injury.2007.08.032. Epub 2008 Jan 29.
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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.
Robert V O'Toole, MD principal investigator
University of Maryland, College Park
Mark Shirtliff, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highly Sensitive Assays in people with Orthopaedic Trauma Infections, run by University of Maryland, Baltimore at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Apr 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays (time frame: Study surgery to 6-month clinical follow-up). 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 NCT03126448, which also lists 19 linked publications.
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 28 Apr 2020.