Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-06-23
Brief Title:
Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy
Sponsor:
Martina Hansens Hospital
Organization:
Martina Hansens Hospital
Study Overview
Official Title:
Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy Using 3D Printed Patient-specific Instrumentation PSI An RCT Comparing Correction Aimed at 62 Versus 55
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
The purpose of this RCT is to investigate whether high tibial osteotomy using 3D printed patient specific guides aiming at 55 correction is non-inferior to aiming at 62
Detailed Description:
HTO should play a major role in modern treatment algorithms for knee overload and osteoarthritis By transferring load from the failingosteoarthritic compartment of the knee to a healthier compartment HTO can delay or stop the progression of osteoarthritis at an early stage This can remove pain and increase knee function making return to work activities and sport possible HTO may delay or avoid the need for total knee replacement for 10 years for at least 80 of patients
The optimal target for the postoperative mechanical axis of the leg is not yet clarified Both under- and overcorrection can lead to unfavourable results The classical Fusjisawas point of 62 or approximately 3 deg of valgus is still often used as the optimal target and studies show good clinical results and longevity With an often accepted accuracy of - 3 deg with conventional methods the accepted postoperative range of valgus will be from 0 deg to 6 deg But the optimal range is possibly much narrower Recent studies suggest a narrower range and less overcorrection
3D-printed patient specific instrumentation PSI is based on CT of the individual patients knee data simulation of the planned correction and subsequent 3D printed guides for each patient The PSI design varies but involves a positioning guide fitting only in position one the proximal tibia a cutting guidance and a wedge opening guide PSI seem to improve accuracy to the level of approximately - 1 deg from the preplanned correction and leads to fewer unacceptable outliers compared to the conventional methods available Improved accuracy has not shown to yield better clinical results
In the future the target axis should possibly be individualized based on the pathology treated gait analyses and data simulations
Modern gait analysis using wearable accelerator sensors often referred to as inertial measurement units IMUs is rapidly evolving By coupling individualized and accurate osteotomy with gait analysis using wearable sensors one could better predict and understand how to normalise each individual patients gait pattern and possibly improve patient satisfaction and function after surgery
By coupling the highly accurate PSI method an angular stable implant and a composite of outcomes based on radiology validated patient reported outcome measures and gait analysis our RCT can investigate if a correction target of 55 is non-inferior to the common 62
The study will be designed as a continuous outcome non-inferiority trial where KOOS QoL subscale is used as the primary outcome and the basis for sample size calculation The Minimal Clinical Important Difference MCID for KOOS QoL regarding HTO is 165 points A presumed standard deviation SD of 23 points is obtained from a previous study on a similar population A one-sided t-test power analysis with 25 significance level and 80 power level indicates that 31 patients would be needed in each group In total 70 patients is planned to be included which takes into account up to 10 dropout rate and some uncertainty regarding the predicted score values
Statistics
The primary outcome will be analyzed with a linear mixed model where the measurements from all time points will be included The main effect measure will be the between-group difference in change from baseline to two years which will be estimated with a 95 confidence interval and a P-value for non-inferiority where the null hypothesis is that osteotomy correction to the 55 target is inferior to the correction to the 62 target and the alternative states that it is not Inferiority is determined by KOOS QOL difference of at least MCID
Paired samples t-tests will be used to analyze differences between pre- and postoperative measurements on X-rays within each group Independent samples t-tests will be used to analyze differences between groups A p-value 005 is considered statistically significant
The optimal target for the postoperative mechanical axis of the leg is not yet clarified Both under- and overcorrection can lead to unfavourable results The classical Fusjisawas point of 62 or approximately 3 deg of valgus is still often used as the optimal target and studies show good clinical results and longevity With an often accepted accuracy of - 3 deg with conventional methods the accepted postoperative range of valgus will be from 0 deg to 6 deg But the optimal range is possibly much narrower Recent studies suggest a narrower range and less overcorrection
3D-printed patient specific instrumentation PSI is based on CT of the individual patients knee data simulation of the planned correction and subsequent 3D printed guides for each patient The PSI design varies but involves a positioning guide fitting only in position one the proximal tibia a cutting guidance and a wedge opening guide PSI seem to improve accuracy to the level of approximately - 1 deg from the preplanned correction and leads to fewer unacceptable outliers compared to the conventional methods available Improved accuracy has not shown to yield better clinical results
In the future the target axis should possibly be individualized based on the pathology treated gait analyses and data simulations
Modern gait analysis using wearable accelerator sensors often referred to as inertial measurement units IMUs is rapidly evolving By coupling individualized and accurate osteotomy with gait analysis using wearable sensors one could better predict and understand how to normalise each individual patients gait pattern and possibly improve patient satisfaction and function after surgery
By coupling the highly accurate PSI method an angular stable implant and a composite of outcomes based on radiology validated patient reported outcome measures and gait analysis our RCT can investigate if a correction target of 55 is non-inferior to the common 62
The study will be designed as a continuous outcome non-inferiority trial where KOOS QoL subscale is used as the primary outcome and the basis for sample size calculation The Minimal Clinical Important Difference MCID for KOOS QoL regarding HTO is 165 points A presumed standard deviation SD of 23 points is obtained from a previous study on a similar population A one-sided t-test power analysis with 25 significance level and 80 power level indicates that 31 patients would be needed in each group In total 70 patients is planned to be included which takes into account up to 10 dropout rate and some uncertainty regarding the predicted score values
Statistics
The primary outcome will be analyzed with a linear mixed model where the measurements from all time points will be included The main effect measure will be the between-group difference in change from baseline to two years which will be estimated with a 95 confidence interval and a P-value for non-inferiority where the null hypothesis is that osteotomy correction to the 55 target is inferior to the correction to the 62 target and the alternative states that it is not Inferiority is determined by KOOS QOL difference of at least MCID
Paired samples t-tests will be used to analyze differences between pre- and postoperative measurements on X-rays within each group Independent samples t-tests will be used to analyze differences between groups A p-value 005 is considered statistically significant
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