Health TrialsbyHealthPanel

RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

ConditionsKnee Arthroplasty, TotalRobotic-assistedOsteoarthritis of the Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDanderyd Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years and older.

Eligible for total knee arthroplasty according to local guidelines and routines.

Willingness to participate in the study.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robot-assisted total knee arthroplasty

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: RTKRExperimental treatment 1 intervention
Group B: TKRActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points

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.

Time frame
24 months after surgery

Secondary outcomes

1

Forgotten Joint Score (FJS), continuous score

FJS is scored from 0 to 100, with higher scores indicating less awareness of the replaced knee.

Time frame
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
2

Knee injury and Osteoarthritis Outcome Score (KOOS)

KOOS assesses knee-related pain, symptoms, activities of daily living, sport/recreation and knee-related quality of life. Each subscale ranges from 0 to 100, with higher scores indicating better outcome.

Time frame
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
3

Self-reported knee instability (ADLS items)

Self-reported slipping/partial giving way and buckling/full giving way are assessed using items from the Activities of Daily Living Scale of the Knee Outcome Survey.

Time frame
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
4

EQ-5D and EQ VAS

Health-related quality of life is assessed using EQ-5D and EQ VAS.

Time frame
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danderyd Hospital

Lead sponsor

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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