Bone InfectionCPPInfectionNCT01677000
Clinical Priority Program-Bone Infection Registry
An observational study of Bone Infection and Staphylococcus Aureus, run by AO Clinical Investigation and Publishing Documentation at 21 sites in 10 countries.
Trial summary
Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Bone Infection, Staphylococcus Aureus
- How many people
- 297 participants
- Where
- 21 sitesin 10 countries
- Study dates
- Jun 2012to 30 Jun 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 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with diagnosis of Staphylococcus aureus bone infection
Who may be able to join
- Patients aged 18 years or older
- Confirmed* oxacillin-/methicillin-sensitive Staphylococcus aureus (OSSA/ MSSA) or methicillin resistant Staphylococcus aureus (MRSA) infection involving a long bone (ie, femur, tibia, fibula, humerus, radius, ulna, and clavicle) with one (or a combination) of the following:
- Osteomyelitis
- Fracture fixation hardware /prosthetic joint infection
- Infection around an arthroplasty
- Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
- Signed written informed consent * Confirmed either by positive culture from baseline examination or by positive culture from a prior examination of the same surgical site and definitely ongoing infection with Staphylococcus aureus according to the treating surgeon
Who cannot join
- Patients who cannot give informed consent
- Patients who cannot attend the follow up visits
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
United States5 sites
University of Missouri Health Care
Columbia, Missouri, 65212
Geisinger Health System
Danville, Pennsylvania, 17822
University of Richmond, Department of Orthopaedic Surgery
Richmond, Virginia, 23298
Unity Hospital
Rochester, New York, 14626
University of Rochester
Rochester, New York, 14642
China5 sites
Beijing University Third Hospital
Beijing, 100191
Southwestern Hospital Chongqing
Chongqing, Chongqing Municipality, 400038
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Queen Mary Hospital
Hong Kong
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, 56003
Germany3 sites
Justus-Liebig-Universität
Giessen, 35592
Berufsgenossenschaftliche Unfallklinik Murnau
Murnau am Staffelsee, Bavaria, 82418
Universitaetsklinikum Regensburg
Regensburg, 93042
Japan2 sites
Hamawaki Orthopaedic Hospital
Hiroshima, 730-0051
Hokkaido University Graduate School of Medicine
Sapporo, Hokkaido, 060-8638
Switzerland1 site
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts
Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include:
- baseline patient attributes;
- surgical approach, implants and technology;
- hospital course;
- surgeon and institutional characteristics;
- longitudinal patient outcome,
- post-procedure complications and revisions,
- serum/tissue/drainage samples.
Read the detailed description
Establish an international registry with AOCID of over 400 patients with deep infections involving the bone and/or joint from ≥ 20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal infection cases will permit better analysis of the causes, contributing factors including patient immune responses, treatments and clinical outcomes of musculoskeletal infections.
- Establish a practice network that includes ≥ 20 geographically distributed centers. These busy practices will be treating patients with varied geographic status to assure balanced representation of diverse patients and practices.
- Establish a Data Coordinating Core team with AOCID using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry.
The registry will include:
- baseline patient attributes
- surgical approach, implants and technology
- hospital course
- surgeon and institutional characteristics
- longitudinal patient outcome
- post-procedure complications and revisions
- serum/tissue/drainage samples
- Establish a Statistical Support team with AOCID to implement cutting-edge statistical techniques including the use of hierarchical generalized linear latent and mixed effects models to address the complex structure and longitudinal nature of registry data. Multivariable predictive models for outcome(s) of infection will be developed.
- Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP team to advance the science of infection-specific and global patient-reported outcomes to support efficient data collection of web-based, longitudinal data in this registry and future comparative effectiveness research.
- Develop new assessment tools and conduct research useful to clinical practice. Establish consensus on the definition of treatment failure- characterized as lack of clinically meaningful improvement in infection, pain or physical function following treatment, validate, and refine prediction algorithms for patients at risk for failure.
- Conditions
- Bone Infection, Staphylococcus Aureus
- Keywords
- bone infection, staphylococcus aureus, registry
- Medical subject headings
- Staphylococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Details on occurence and treatment of bone infection
Measured: 1 December 2012
Secondary outcomes (3)
Surgical approach, implants and technology
Measured: 01 December 2012
Patient outcome
Measured: 01 December 2012
Post-procedure complications and revisions
Measured: 01 December 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startJun 2012
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone InfectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen L Kates, MD, Principal investigator, University of Richmond
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677000
- Sponsor's protocol ID
- CPP Infection Registry
- Acronym
- CPPInfection
- Status last verified
- Aug 2020
- First submitted
- 29 Aug 2012
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts
- ClinicalTrials.gov ID
- NCT01677000
- Acronym / sponsor ID
- CPPInfection / CPP Infection Registry
- Conditions
- Bone Infection, Staphylococcus Aureus
- Keywords
- bone infection, staphylococcus aureus, registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 Aug 2012 (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.
Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include:
- baseline patient attributes;
- surgical approach, implants and technology;
- hospital course;
- surgeon and institutional characteristics;
- longitudinal patient outcome,
- post-procedure complications and revisions,
- serum/tissue/drainage samples.
Detailed description
Establish an international registry with AOCID of over 400 patients with deep infections involving the bone and/or joint from ≥ 20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal infection cases will permit better analysis of the causes, contributing factors including patient immune responses, treatments and clinical outcomes of musculoskeletal infections.
- Establish a practice network that includes ≥ 20 geographically distributed centers. These busy practices will be treating patients with varied geographic status to assure balanced representation of diverse patients and practices.
- Establish a Data Coordinating Core team with AOCID using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry.
The registry will include:
- baseline patient attributes
- surgical approach, implants and technology
- hospital course
- surgeon and institutional characteristics
- longitudinal patient outcome
- post-procedure complications and revisions
- serum/tissue/drainage samples
- Establish a Statistical Support team with AOCID to implement cutting-edge statistical techniques including the use of hierarchical generalized linear latent and mixed effects models to address the complex structure and longitudinal nature of registry data. Multivariable predictive models for outcome(s) of infection will be developed.
- Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP team to advance the science of infection-specific and global patient-reported outcomes to support efficient data collection of web-based, longitudinal data in this registry and future comparative effectiveness research.
- Develop new assessment tools and conduct research useful to clinical practice. Establish consensus on the definition of treatment failure- characterized as lack of clinically meaningful improvement in infection, pain or physical function following treatment, validate, and refine prediction algorithms for patients at risk for failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diagnosis of Staphylococcus aureus bone infection
Key inclusion criteria (7 listed)
- Patients aged 18 years or older
- Confirmed* oxacillin-/methicillin-sensitive Staphylococcus aureus (OSSA/ MSSA) or methicillin resistant Staphylococcus aureus (MRSA) infection involving a long bone (ie, femur, tibia, fibula, humerus, radius, ulna, and clavicle) with one (or a combination) of the following:
- Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
- Signed written informed consent * Confirmed either by positive culture from baseline examination or by positive culture from a prior examination of the same surgical site and definitely ongoing infection with Staphylococcus aureus according to the treating surgeon
Key exclusion criteria (4 listed)
- Patients who cannot give informed consent
- Patients who cannot attend the follow up visits
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Details on occurence and treatment of bone infection
Time frame: 1 December 2012
3 secondary outcomes
Surgical approach, implants and technology
Time frame: 01 December 2012
Patient outcome
Time frame: 01 December 2012
Post-procedure complications and revisions
Time frame: 01 December 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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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.
Stephen L Kates, MD principal investigator
University of Richmond
21 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Infection and Staphylococcus Aureus, run by AO Clinical Investigation and Publishing Documentation at 21 sites in 10 countries.
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 7 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, China, Germany, Japan, Argentina and 5 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Details on occurence and treatment of bone infection (time frame: 1 December 2012). 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 13 Aug 2020.