Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389435
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-04
Brief Title:
RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Sponsor:
Danderyd Hospital
Organization:
Danderyd Hospital
Study Overview
Official Title:
ROCKETS RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized Multicenter Preference-tolerant Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ROCKETS
Brief Summary:
Rationale for conducting the study
The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement RTKR compared to conventional Total Knee Replacement TKR It focuses on the potential benefits of RTKR including improved precision in surgery potentially leading to better patient outcomes and reduced healthcare costs Our primary endpoint is the Forgotten Joint Score FJS aimed at measuring patients awareness of their knee joint in everyday life indicating the success of the knee replacement surgery in restoring natural joint function Secondary endpoints include patient-reported outcome measures PROMs patient activity levels the accuracy of implant positioning on x-ray and the incidence of adverse events
Study design
Multicentre preference-tolerant randomized controlled superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques
Study population
Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study
Number of patients
400
Inclusion criteria
Patients must be adults aged 18 years and older eligible for TKR according to local guidelines and willing to participate in the study
Exclusion criteria
Patients with extreme malalignment requiring special implants or techniques patients unfit for surgery due to medical reasons and those deemed unsuitable to participate in the study for other reasons
Primary outcome variables
The Forgotten Joint Score FJS at 2 years after surgery
The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement RTKR compared to conventional Total Knee Replacement TKR It focuses on the potential benefits of RTKR including improved precision in surgery potentially leading to better patient outcomes and reduced healthcare costs Our primary endpoint is the Forgotten Joint Score FJS aimed at measuring patients awareness of their knee joint in everyday life indicating the success of the knee replacement surgery in restoring natural joint function Secondary endpoints include patient-reported outcome measures PROMs patient activity levels the accuracy of implant positioning on x-ray and the incidence of adverse events
Study design
Multicentre preference-tolerant randomized controlled superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques
Study population
Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study
Number of patients
400
Inclusion criteria
Patients must be adults aged 18 years and older eligible for TKR according to local guidelines and willing to participate in the study
Exclusion criteria
Patients with extreme malalignment requiring special implants or techniques patients unfit for surgery due to medical reasons and those deemed unsuitable to participate in the study for other reasons
Primary outcome variables
The Forgotten Joint Score FJS at 2 years after surgery
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Knee | OTHER | Danderyds sjukhus | None |