Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264999
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-12-28
Brief Title:
Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
Gait Analysis Stair Performance and CT-based Micromotion Analysis in Robotic Assisted Total Knee Arthroplasty Comparing Bi-cruciate Retaining vs Cruciate Retaining Implants A Single Centre Patient-blinded Randomized Controlled Trial
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:
None
Brief Summary:
The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty
The main questions it aims to answer are
Does retaining the anterior cruciate ligament improve postoperative gait Participants will perform
Gait analysis
Stair performance test
CT based Micromotion analysis of the implant micromovement
The main questions it aims to answer are
Does retaining the anterior cruciate ligament improve postoperative gait Participants will perform
Gait analysis
Stair performance test
CT based Micromotion analysis of the implant micromovement
Detailed Description:
A randomized controlled clinical trial intended to compare walking function and movement of the prosthesis after robot-assisted knee replacement surgery with two knee replacement designs One prosthesis is preserving the anterior cruciate ligament SmithNephew Journey II XR and the other is sacrificing the anterior cruciate ligament SmithNephew Jourrney II CR
It is common to remove anterior cruciate ligament during knee replacement surgery There is speculation about this weakens the balance in the operated knee and whether this can explain some of the problems that up to 20 experience after knee replacement surgery
Preservation of the anterior cruciate ligament during knee replacement surgery may provide a more natural movement and better balance in the operated knee and this in turn could provide increased patient satisfaction
Previous studies have shown that knee replacement surgery where the anterior cruciate ligament is preserved has an increased incidence of per- and postoperative complications and reduced implant survival Robot assisted navigation in knee arthroplasty surgery has shown the possibility of increased precision and accuracy when implanting the knee prostheses and therefore might provide increased satisfaction when performing elective knee prosthetic surgery with robotic assistance and at the same time preserving the anterior cruciate ligament without an increased risk of complications
In this study postoperative function is assessed by looking at whether the walking pattern has normalized
Gait analyses with comparison of the two groups is carried out both before surgery and 2 6 and 12 months after surgery
Primary endpoint is self-selected walking speed at 12 months follow-up Secondary endpoints include other gait analysis parameters result of stair test as well as patient-reported pain satisfaction and function NRS EQ-5D-5L KOOS-PS IKSS FJS-12 knee mobility stability and hip-knee-ankle angle
Complications related to the surgery or the course afterwards is noted The study will also compare the movement of the prosthetic components in relation to the skeleton over a period of 2 years using a CT based micro motion analysis method CT-RSA making it possible to assess implant migration over time
Increased movement can predict early loosening of the prosthesis
It is common to remove anterior cruciate ligament during knee replacement surgery There is speculation about this weakens the balance in the operated knee and whether this can explain some of the problems that up to 20 experience after knee replacement surgery
Preservation of the anterior cruciate ligament during knee replacement surgery may provide a more natural movement and better balance in the operated knee and this in turn could provide increased patient satisfaction
Previous studies have shown that knee replacement surgery where the anterior cruciate ligament is preserved has an increased incidence of per- and postoperative complications and reduced implant survival Robot assisted navigation in knee arthroplasty surgery has shown the possibility of increased precision and accuracy when implanting the knee prostheses and therefore might provide increased satisfaction when performing elective knee prosthetic surgery with robotic assistance and at the same time preserving the anterior cruciate ligament without an increased risk of complications
In this study postoperative function is assessed by looking at whether the walking pattern has normalized
Gait analyses with comparison of the two groups is carried out both before surgery and 2 6 and 12 months after surgery
Primary endpoint is self-selected walking speed at 12 months follow-up Secondary endpoints include other gait analysis parameters result of stair test as well as patient-reported pain satisfaction and function NRS EQ-5D-5L KOOS-PS IKSS FJS-12 knee mobility stability and hip-knee-ankle angle
Complications related to the surgery or the course afterwards is noted The study will also compare the movement of the prosthetic components in relation to the skeleton over a period of 2 years using a CT based micro motion analysis method CT-RSA making it possible to assess implant migration over time
Increased movement can predict early loosening of the prosthesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None