RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
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- Who runs it
- Danderyd Hospital
- Trial code
- NCT06389435
- Record updated
- 21 September 2026
- Original description
Rationale for conducting the study:Read full original descriptionShow less
ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study
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: Adults aged 18 years and older; Eligible for total knee arthroplasty according to local guidelines and routines; Willingness to participate in the study.
Exclusion: 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.