RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

Condition(s) studied

Investigational drug(s) / intervention(s)

Robot-assisted total knee arthroplasty: Robot-assisted total knee arthroplasty using an approved robotic surgical system to assist intraoperative planning, bone preparation, implant positioning and balancing according to the participating centre's approved technique.

Conventional total knee arthroplasty: Conventional total knee arthroplasty using standard manual instrumentation according to local clinical routine.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points — 24 months after surgery
  The primary endpoint is the proportion of randomized participants achieving an FJS of ≥80 points at 24 months after surgery. The FJS ranges from 0 to 100, with higher scores indicating less awareness of the replaced knee during everyday activities.

Trial sites (2)

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