RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques (ROCKETS)

Danderyd Hospital

Status: Enrolling

Conditions: Osteoarthritis of the Knee; Knee Arthroplasty, Total; Robotic-assisted

Treatments: Procedure: Patients will be randomized to undergo TKR or RTKR

Study type: Interventional

Funder types: Other

Identifiers

NCT06389435

Knee (Other Identifier)

2024DS

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

RTKR

Experimental group

Description:

Robotic assisted total knee replacement (RTKR)

Treatment:

Procedure: Patients will be randomized to undergo TKR or RTKR

TKR

Active Comparator group

Description:

Standard total knee replacement (TKR)

Treatment:

Procedure: Patients will be randomized to undergo TKR or RTKR