Clinical trial NCT06389435: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Official title: ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthroplasty, Total
Robotic-assisted
Osteoarthritis of the Knee
Keywords: Knee arthroplasty
Robotic assisted
Osteoartritis
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Stockholm South General Hospital
First posted: 2024-04-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older.
* Eligible for TKR according to local guidelines and routines.
* Willingness to participate in the study.

Exclusion Criteria:

* Patients with extreme malalignment necessitating special implants or techniques.
* Patients unfit for surgery due to other medical reasons.
* Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study.
* Patients who, for other reasons can't fulfill the required patient recorded outcome measures

Primary outcomes:
measure: The Forgotten Joint Score (FJS)
timeFrame: 24 months post surgery
Secondary outcomes:
measure: KOOS
timeFrame: preop, 6 weeks, 12 and 24 months post surgery
measure: ADLS knee instability
timeFrame: 6 weeks, 12 and 24 months post-operation.
measure: The Forgotten Joint Score (FJS)
timeFrame: 6 weeks and 12 months post surgery
measure: EQ-5D
timeFrame: 6 weeks, 12 and 24 months post surgery
measure: Knee alignment
timeFrame: 6 weeks post surgery
measure: Adverse events
timeFrame: up to 24 months post surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus
Study officials:
References: