Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05729958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-01-17
Brief Title:
Total Ankle Replacement Using Guides Expert Versus Trainee
Sponsor:
Centre for Orthopaedic Research Alkmaar
Organization:
Centre for Orthopaedic Research Alkmaar
Study Overview
Official Title:
Total Ankle Replacement Using Guides Expert Versus Trainee
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
TARGET
Brief Summary:
Patient Specific Instrumentation PSI is thought to quicken joint arthroplasty surgery by shortening the operation time and improving alignment Studies about the learning curve of PSI for total ankle replacement TAR are lacking because it was only introduced in 2014
The investigators believe that PSI could give a beginning ankle surgeon or surgeons new to TAR an advantage since PSI facilitates the complex TAR procedure As such the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended To estimate this potential of PSI for TAR the investigators aim 1 to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon and 2 to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time complications and patient-reported outcomes with those of an experienced specialist
The investigators believe that PSI could give a beginning ankle surgeon or surgeons new to TAR an advantage since PSI facilitates the complex TAR procedure As such the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended To estimate this potential of PSI for TAR the investigators aim 1 to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon and 2 to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time complications and patient-reported outcomes with those of an experienced specialist
Detailed Description:
Total ankle replacement TAR as treatment of end-stage osteoarthritis of the ankle is gaining popularity past few years resulting in a growing number of TAR placed each year This is an important progression because osteoarthritis of the ankle is suggested to be as disabling as chronic kidney injury or heart failure Though TAR is proposed to be superior to ankle arthrodesis AA with regard to patient quality of life it is not commonly available in the Netherlands Merely 149 TARs were registered nationally in 2020
Patient Specific Instrumentation PSI is thought to quicken the process by shortening the operation time and improving alignment Though the literature is submerged in studies about the learning curves of PSI and TAR research about the learning curve of PSI TAR is lacking because it was only introduced in 2014 Preliminary results showed that the use of PSI resulted in lower average pain scores and earlier recovery compared to TAR using standard instrumentation Yet the absolute advantage of PSI was not established because of limited research Furthermore all previous studies were performed by skilled surgeons to eliminate the bias of inexperience
The investigators believe that PSI could give a beginning ankle surgeon or surgeon new to TAR an advantage since PSI facilitates the complex TAR procedure As such the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended To estimate this potential of PSI for TAR the investigators aim 1 to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon and 2 to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time complications and patient-reported outcomes with those of an experienced specialist It is hypothesized that the alignment of PSI TAR performed by a beginning orthopedic surgeon does not significantly differ from one performed by an experienced surgeon Furthermore it is hypothesized that the operative time complications and patient-reported outcomes do not significantly differ between a beginning and an experienced orthopedic surgeon
Patient Specific Instrumentation PSI is thought to quicken the process by shortening the operation time and improving alignment Though the literature is submerged in studies about the learning curves of PSI and TAR research about the learning curve of PSI TAR is lacking because it was only introduced in 2014 Preliminary results showed that the use of PSI resulted in lower average pain scores and earlier recovery compared to TAR using standard instrumentation Yet the absolute advantage of PSI was not established because of limited research Furthermore all previous studies were performed by skilled surgeons to eliminate the bias of inexperience
The investigators believe that PSI could give a beginning ankle surgeon or surgeon new to TAR an advantage since PSI facilitates the complex TAR procedure As such the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended To estimate this potential of PSI for TAR the investigators aim 1 to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon and 2 to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time complications and patient-reported outcomes with those of an experienced specialist It is hypothesized that the alignment of PSI TAR performed by a beginning orthopedic surgeon does not significantly differ from one performed by an experienced surgeon Furthermore it is hypothesized that the operative time complications and patient-reported outcomes do not significantly differ between a beginning and an experienced orthopedic surgeon
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