Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06389435
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Sponsor:
Danderyd Hospital
Organization:
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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Knee | OTHER | Danderyds sjukhus | View |