Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01677000
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2012-08-29
Brief Title:
Clinical Priority Program-Bone Infection Registry
Sponsor:
AO Clinical Investigation and Publishing Documentation
Organization:
AO Innovation Translation Center
Study Overview
Official Title:
Clinical Priority Program Bone Infection Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPPInfection
Brief Summary:
Establish an international registry of over 400 patients with deep infections involving the bone andor joint from20 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
1 baseline patient attributes
2 surgical approach implants and technology
3 hospital course
4 surgeon and institutional characteristics
5 longitudinal patient outcome
6 post-procedure complications and revisions
7 serumtissuedrainage samples
1 baseline patient attributes
2 surgical approach implants and technology
3 hospital course
4 surgeon and institutional characteristics
5 longitudinal patient outcome
6 post-procedure complications and revisions
7 serumtissuedrainage samples
Detailed Description:
Establish an international registry with AOCID of over 400 patients with deep infections involving the bone andor 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
serumtissuedrainage 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 outcomes 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
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
serumtissuedrainage 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 outcomes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None