RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

Rationale for conducting the study: The ROCKET study evaluates the clinical and economic outcomes of robot-assisted total knee arthroplasty (RTKR) compared with conventional total knee arthroplasty (TKR). The primary endpoint is the proportion of randomized participants achieving a Forgotten Joint Score (FJS) of ≥80 points at 24 months after surgery. Secondary outcomes include patient-reported knee function, health-related quality of life, self-reported instability, physical activity, radiographic alignment, surgical and technical outcomes, complications, reoperations, revisions, and health-economic outcomes. Study design: International multicentre, preference-tolerant, randomized, controlled superiority trial with two treatment arms comparing RTKR with conventional TKR. Participants in the randomized part are allocated 1:1. At selected centres where feasible, an optional participant-blinded randomized component may be implemented. Eligible patients who do not undergo randomization may participate in a parallel observational/preference cohort, which is analysed separately from the primary randomized comparison. Study population: Adults aged 18 years and older who are eligible for total knee arthroplasty according to local guidelines and who provide informed consent. Number of patients: Up to 1,600 randomized participants. Eligible non-randomized participants may additionally be included in the observational/preference cohort. Primary outcome: Proportion of randomized participants achieving FJS ≥80 points at 24 months after surgery. Long-term follow-up: Patient-reported and registry-based outcomes are planned at 5 and 10 years after surgery where feasible.

Inclusion Criteria: * Adults aged 18 years and older. * Eligible for total knee arthroplasty 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 reasons such as alcohol or substance abuse, are deemed unsuitable to participate in the study. * Patients who, for other reasons, cannot fulfil the required patient-reported outcome measures.