Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499038
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-03
Brief Title:
The Ace Avanteon Study - A Randomized Controled Trial
Sponsor:
Helse Møre og Romsdal HF
Organization:
Helse Møre og Romsdal HF
Study Overview
Official Title:
Migration Analysis of a Hybrid Hip Replacement Evaluating Stem and Ancillary Acetabular Screw Fixation-A Randomized Controlled CT-RSA Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The goal of this randomized controled trial is to compare if using of ancillary screws yields equal results as no use of ancillary screws in the ACE acetabulum cup of a total hip arthroplasty Further the migration of the Avanteon stem over time will be assessed Patients included are patients with hip osteoarthritis from 65-80 years old The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem by using CT based Radiostereometric Analysis a new innovative method for evaluating implant migration Our study may predict the long term survival of the implants used
Participants will go through total hip arthroplasty and be followed by CT-RSA plain x-rays and patients reported outcome measures
Participants will go through total hip arthroplasty and be followed by CT-RSA plain x-rays and patients reported outcome measures
Detailed Description:
Hip and knee osteoarthritis OA is one of the leading causes of disability worldwide The lifetime risk of developing hip OA is estimated to be 25 in people who reach the age of 85 Total hip replacement THR is considered to be a safe and reliable surgical treatment for end stage hip OA and was described as Surgery of the century One of the challenges in hip replacement surgery is to ensure the longevity and durability of the implants used New implants are designed to improve the primary stability and long-term survival of the implant Early failure of implants and the need for revision surgery is a major concern Revision hip replacement surgery is a surgical procedure with high rates of postoperative complications and overall re-revision rate of 158 within 1 year In the Norwegian arthroplasty register 10 year failure rate of hip revision prostheses is 26 Thus the longevity and durability of implants is a continuous challenge in which the ultimate goal is to develop well-functioning implants which will last a lifetime
The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem by using CT based Radiostereometric Analysis a new innovative method for evaluating implant migration Our study may predict the long term survival of the implants used This will be the first ever CT-RSA study in Norway and one of the first world-wide evaluating hip implants
Radiostereometric analysis RSA is a method used to measure implant migration and micromotion after joint replacement surgery with high precision and accuracy It is considered the gold standard for to assess migration in orthopedic implants Early implant migration predicts later loosening and failure of the implant Subsidence of the femoral stem of more than 12 mm at 24m months is predictive of revision Proximal migration of the acetabular component of up to 02mm is considered acceptable 02-1mm is considered at risk and above 1mm is unacceptable RSA is thereby used as an early measure of longevity and durability of new implants However RSA is an expensive and time consuming procedure It requires special equipment such as RSA cages software and special x-ray setup It also requires specially trained personnel to do the examination Loss of data due to occlusion of tantalum beads from metallic implants is unavoidable in RSA Over the last years CT-RSA has evolved to overcome some of the challenges of RSA CT-RSA has been validated to have similar or even higher precision and accuracy than RSA in both hip and knee implant analysisBy using CT-RSA we can evaluate implant migration without the need for implant or bone markers by using bone surface anatomy One of the authors FDØ has recently shown that a vast decrease of effective radiation doses of CT-RSA in total knee arthroplasty yields equal precision in a cadaver study publication in press We assume this applies to CT-RSA of the hip as well We therefore would like to perform a study on ultra low dose CT-RSA of hip implants to evaluate the precision This could have a major impact for future CT-RSA studies of the hip since we potentially could reduce the effective radiation dose
Previous cadaveric studies have shown that screw fixation increases initial stability of acetabular components In long term press-fit screwless fixation achieve sufficient stabilityThe use of augmented screw fixation may increase the risk of particle debris and osteolysis around the acetabular component The use of ancillary screw fixation may thereby increase the risk of loosening and need for major revision surgery There is also a risk for iatrogenic damage to nearby vessels and pelvic organs due to screw misplacement
The Avanteon JRI is a highly polished double tapered femoral stem designed by force-closed principles The stem is intended to subside gradually in the cement mantle over time Highly polished femoral stems have shown excellent results and lower revision rates compared to shape-closed design stems New implants are developed to increase early fixation and long term survival to avoid the need for revision surgery
In the field of orthopedic surgery our study may predict the long term survival of the implants used and thereby contributing to the goal of life-long lasting implants This will also contribute to lower the need for revision surgery avoiding the risk of major complications for our patients The economic impact off revision surgery is of great concern for both the patient and the society and avoiding the need for revision arthroplasty is of economic importance
Research questions and goals In our study we will evaluate the migration of the Avanteon femoral stem using CT-RSA to predict long-term survival We will also evaluate the role of ancillary screw fixation of the new ACE acetabular component by using CT-RSA to see if ancillary screw fixation increases stability of the implant By using a patient attached accelerometer-based activity monitor ActivePAL we can measure patient activity to see if the screw fixation has any effect on activity levels
Hypotheses Article 1
H0-hypothesis subsidence of the Avanteon femoral stem is less than 12mm at 24 months
H1-hypothesis subsidence of the Avanteon femoral stem is more than 12mm at 24 months
Article 2
H0-hypothesis ancillary screw fixation of the ACE acetabular component does not increase stability of the implant
H1-hypothesis ancillary screw fixation of the ACE acetabular component increases stability of the implant
Article 3
H0-hypothesis ancillary screw fixation of the ACE acetabular component does not increase patient activity
H1-hypothesis ancillary screw fixation of the ACE acetabular component increases patient activity
Article 4
H0-hypothesis reducing the effective radiation dose does not reduce the precision of CT-RSA of hip implants
H1-hypothesis reducing the effective radiation dose reduce the precision of CT-RSA of hip implants
Short term goals
Demonstrating the stability and migration of the Avanteon femoral stem
Evaluate the stability and migration of the ACE acetabular component with and without ancillary screw fixation
Demonstrate the clinical efficacy and safety of the ACE acetabular component and Avanteon femoral stem
Demonstrate the effect of acetabular screw fixation on patient activity levels in the postoperative period Demonstrate the precision of ultra low dose CT-RSA Long term goals
Contributing to the development of longer lasting hip replacement implants
Evaluate the increase in activity levels after hip replacement surgery
Results expected to be achieved during the project period
Establishing the new innovative CT-RSA as a method for hip implant migration analysis in Norway
Develop recommendation for the routine use of ancillary screw fixation of acetabular components
This is a single blinded randomized controlled trial Eligible patients referred will be evaluated for inclusion consecutively from the outpatient clinic of the research department at Kristiansund hospital
The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem by using CT based Radiostereometric Analysis a new innovative method for evaluating implant migration Our study may predict the long term survival of the implants used This will be the first ever CT-RSA study in Norway and one of the first world-wide evaluating hip implants
Radiostereometric analysis RSA is a method used to measure implant migration and micromotion after joint replacement surgery with high precision and accuracy It is considered the gold standard for to assess migration in orthopedic implants Early implant migration predicts later loosening and failure of the implant Subsidence of the femoral stem of more than 12 mm at 24m months is predictive of revision Proximal migration of the acetabular component of up to 02mm is considered acceptable 02-1mm is considered at risk and above 1mm is unacceptable RSA is thereby used as an early measure of longevity and durability of new implants However RSA is an expensive and time consuming procedure It requires special equipment such as RSA cages software and special x-ray setup It also requires specially trained personnel to do the examination Loss of data due to occlusion of tantalum beads from metallic implants is unavoidable in RSA Over the last years CT-RSA has evolved to overcome some of the challenges of RSA CT-RSA has been validated to have similar or even higher precision and accuracy than RSA in both hip and knee implant analysisBy using CT-RSA we can evaluate implant migration without the need for implant or bone markers by using bone surface anatomy One of the authors FDØ has recently shown that a vast decrease of effective radiation doses of CT-RSA in total knee arthroplasty yields equal precision in a cadaver study publication in press We assume this applies to CT-RSA of the hip as well We therefore would like to perform a study on ultra low dose CT-RSA of hip implants to evaluate the precision This could have a major impact for future CT-RSA studies of the hip since we potentially could reduce the effective radiation dose
Previous cadaveric studies have shown that screw fixation increases initial stability of acetabular components In long term press-fit screwless fixation achieve sufficient stabilityThe use of augmented screw fixation may increase the risk of particle debris and osteolysis around the acetabular component The use of ancillary screw fixation may thereby increase the risk of loosening and need for major revision surgery There is also a risk for iatrogenic damage to nearby vessels and pelvic organs due to screw misplacement
The Avanteon JRI is a highly polished double tapered femoral stem designed by force-closed principles The stem is intended to subside gradually in the cement mantle over time Highly polished femoral stems have shown excellent results and lower revision rates compared to shape-closed design stems New implants are developed to increase early fixation and long term survival to avoid the need for revision surgery
In the field of orthopedic surgery our study may predict the long term survival of the implants used and thereby contributing to the goal of life-long lasting implants This will also contribute to lower the need for revision surgery avoiding the risk of major complications for our patients The economic impact off revision surgery is of great concern for both the patient and the society and avoiding the need for revision arthroplasty is of economic importance
Research questions and goals In our study we will evaluate the migration of the Avanteon femoral stem using CT-RSA to predict long-term survival We will also evaluate the role of ancillary screw fixation of the new ACE acetabular component by using CT-RSA to see if ancillary screw fixation increases stability of the implant By using a patient attached accelerometer-based activity monitor ActivePAL we can measure patient activity to see if the screw fixation has any effect on activity levels
Hypotheses Article 1
H0-hypothesis subsidence of the Avanteon femoral stem is less than 12mm at 24 months
H1-hypothesis subsidence of the Avanteon femoral stem is more than 12mm at 24 months
Article 2
H0-hypothesis ancillary screw fixation of the ACE acetabular component does not increase stability of the implant
H1-hypothesis ancillary screw fixation of the ACE acetabular component increases stability of the implant
Article 3
H0-hypothesis ancillary screw fixation of the ACE acetabular component does not increase patient activity
H1-hypothesis ancillary screw fixation of the ACE acetabular component increases patient activity
Article 4
H0-hypothesis reducing the effective radiation dose does not reduce the precision of CT-RSA of hip implants
H1-hypothesis reducing the effective radiation dose reduce the precision of CT-RSA of hip implants
Short term goals
Demonstrating the stability and migration of the Avanteon femoral stem
Evaluate the stability and migration of the ACE acetabular component with and without ancillary screw fixation
Demonstrate the clinical efficacy and safety of the ACE acetabular component and Avanteon femoral stem
Demonstrate the effect of acetabular screw fixation on patient activity levels in the postoperative period Demonstrate the precision of ultra low dose CT-RSA Long term goals
Contributing to the development of longer lasting hip replacement implants
Evaluate the increase in activity levels after hip replacement surgery
Results expected to be achieved during the project period
Establishing the new innovative CT-RSA as a method for hip implant migration analysis in Norway
Develop recommendation for the routine use of ancillary screw fixation of acetabular components
This is a single blinded randomized controlled trial Eligible patients referred will be evaluated for inclusion consecutively from the outpatient clinic of the research department at Kristiansund hospital
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