Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752007
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2020-10-27
Brief Title:
Movement of the Sacroiliac SI Joint Comparing Conventional RSA With the Sectra Implant Movement Analysis
Sponsor:
University of Bergen
Organization:
University of Bergen
Study Overview
Official Title:
Accuracy of the CT-Implant Movement Analysis A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2022-06
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:
IMSRA
Brief Summary:
Movement of the Sacroiliac SI Joint comparing conventional RSA with the Sectra Implant Movement analysis using a low dose CT for high accuracy measurement A feasibility study for a future kohort study
Detailed Description:
Abstract Background Radiostereometric analysis RSA is a high precision in vivo measuring method and regarded as the gold standard for motion analysis RSA has been around for over 40 years and its accuracy is properly evaluated The CT technics have evolved and now low dose CT scans can reproduce 3-D models of bone and joints The Sectra Implant Movement analysis IMA is a new method using a low dose CT for high accuracy measurement There is no study evaluating the precision and accuracy of the new CT based methodThe investigator want to compare the accuracy of the two methods
Methoddesign The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies conducted at Ullevål University Hospital There are 2-6 patients in the age of 40-50 years available for RSA analysis with and without provocation of the SI joints Some are fused in one SI joint after insertion of the tantalum markers but the contralateral joint can then be used for the analysis At the same timethe investigator will perform low dose CT with and without provocation of the SI joints The results of the analysis will be compared
Discussion The conventional RSA is an invasive method using tantalum markers inserted in to bone If the CT method has the same accuracy then the tantalum markers will become obsolete and future studies can easily be performed using non-invasive low dose CT scans
Keywords RSA CT method low dose CT IS joint movement
Introduction
Because of the high accuracy and precision radiostereometric analysis RSA has become a well- established method for three-dimensional 3-D measurements of micro motion in joints The implantation of tantalum markers is invasive but no reports of patient injuries are reported The markers might be inserted through the approach used during a surgical intervention or in an extra stab incisions in the skin to get the markers to the necessary position in the bony structures The placements of the markers are of outmost importance to achieve good quality measurements At least three no collinear markers in each segment and a good distance and distribution in all three axes X Z Y is essential for a good 3-D configuration
The CT techniques have evolved and now low dose CT scans can reproduce 3-D models of bone and joints The Sectra Implant movement analysis IMA is a non-invasive method using a low dose CT scan No tantalum markers are needed and joint provocation can easily be conducted in the CT The CT scan is then sent to the Sectra AB for analysis
Method
Patients and methods
The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies approximately five years ago conducted at Ullevål University Hospital These are patients with long lasting severe sacroiliac joint pain There are six patients in the age of 40-50 years available for RSA analysis with and without provocation of the SI joints at the same time the investigator will perform low dose CT with and without provocation of the SI joints For the non-provocation the patient will be in a supine-position The provocation x-raylow dose CT will be performed 1 anterior straight leg raise 2 One side figure of four position both with 1kg of load Some are fused in one SI joint after insertion of the tantalum markers but the contralateral joint can then be used for the analysis The investigators will also measure eventual movement in the fused joint and the symphysis if tantalum markers present The Center for Implant and Radiostereometric Research Oslo has extensive experience with RSA and established state of the art measuring method of movement in the SI joint They will perform the RSA measurements The CT scan is send to the Sectra AB for analysis
Statistical analysis
Null hypothesis H0 There is no difference in the accuracy Alternate Hypothesis H1 There is a difference in the accuracy Continuous variables will be described with mean and standard deviation and the normality of the data will be checked using the histograms QQ-plots and the Kolmogorov-Smirnov-Test of normality The differences of motion will also be tested for normality The paired sample T-test will be used to detect possible significance in the difference between the two groups Non-parametric tests are used if the assumption of normality does not hold All analysis will be conducted using commercially available software SPSS version 24 IBM Inc and the level of significance is set to p005 in a two-sided test
Participants Project leader and responsible institution Stephan M Röhrl PhD MD Ass Professor Head of Center for Implant and Radiostereometric Research Oslo President of Knee and Hip Register Oslo University Hospital Oslo Norway
PhD candidate Vinjar Myklevoll MD Haukeland University Hospital Bergen Collaborating partner Thomas Kibsgård Ass Professor PhD MD President Pelvic Girdle Pain Society Head of Department Rikshospitalet Oslo OUS
Methoddesign The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies conducted at Ullevål University Hospital There are 2-6 patients in the age of 40-50 years available for RSA analysis with and without provocation of the SI joints Some are fused in one SI joint after insertion of the tantalum markers but the contralateral joint can then be used for the analysis At the same timethe investigator will perform low dose CT with and without provocation of the SI joints The results of the analysis will be compared
Discussion The conventional RSA is an invasive method using tantalum markers inserted in to bone If the CT method has the same accuracy then the tantalum markers will become obsolete and future studies can easily be performed using non-invasive low dose CT scans
Keywords RSA CT method low dose CT IS joint movement
Introduction
Because of the high accuracy and precision radiostereometric analysis RSA has become a well- established method for three-dimensional 3-D measurements of micro motion in joints The implantation of tantalum markers is invasive but no reports of patient injuries are reported The markers might be inserted through the approach used during a surgical intervention or in an extra stab incisions in the skin to get the markers to the necessary position in the bony structures The placements of the markers are of outmost importance to achieve good quality measurements At least three no collinear markers in each segment and a good distance and distribution in all three axes X Z Y is essential for a good 3-D configuration
The CT techniques have evolved and now low dose CT scans can reproduce 3-D models of bone and joints The Sectra Implant movement analysis IMA is a non-invasive method using a low dose CT scan No tantalum markers are needed and joint provocation can easily be conducted in the CT The CT scan is then sent to the Sectra AB for analysis
Method
Patients and methods
The RSA method will be tested in patients that already have tantalum markers inserted around the SI joints from earlier studies approximately five years ago conducted at Ullevål University Hospital These are patients with long lasting severe sacroiliac joint pain There are six patients in the age of 40-50 years available for RSA analysis with and without provocation of the SI joints at the same time the investigator will perform low dose CT with and without provocation of the SI joints For the non-provocation the patient will be in a supine-position The provocation x-raylow dose CT will be performed 1 anterior straight leg raise 2 One side figure of four position both with 1kg of load Some are fused in one SI joint after insertion of the tantalum markers but the contralateral joint can then be used for the analysis The investigators will also measure eventual movement in the fused joint and the symphysis if tantalum markers present The Center for Implant and Radiostereometric Research Oslo has extensive experience with RSA and established state of the art measuring method of movement in the SI joint They will perform the RSA measurements The CT scan is send to the Sectra AB for analysis
Statistical analysis
Null hypothesis H0 There is no difference in the accuracy Alternate Hypothesis H1 There is a difference in the accuracy Continuous variables will be described with mean and standard deviation and the normality of the data will be checked using the histograms QQ-plots and the Kolmogorov-Smirnov-Test of normality The differences of motion will also be tested for normality The paired sample T-test will be used to detect possible significance in the difference between the two groups Non-parametric tests are used if the assumption of normality does not hold All analysis will be conducted using commercially available software SPSS version 24 IBM Inc and the level of significance is set to p005 in a two-sided test
Participants Project leader and responsible institution Stephan M Röhrl PhD MD Ass Professor Head of Center for Implant and Radiostereometric Research Oslo President of Knee and Hip Register Oslo University Hospital Oslo Norway
PhD candidate Vinjar Myklevoll MD Haukeland University Hospital Bergen Collaborating partner Thomas Kibsgård Ass Professor PhD MD President Pelvic Girdle Pain Society Head of Department Rikshospitalet Oslo OUS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None