Robotic-assisted knee replacement is heavily marketed, and patients often ask about it directly. If a robot positions the implant more precisely, will my knee replacement work better? When this entry first appeared in September it summarised a 2023 review of twelve randomised trials, and it closed by noting that larger trials using current robotic systems were still reporting. Two of them have now reported, in The Lancet and The Bone & Joint Journal, and this entry has been rewritten around them. One is British and one is Australian. The Australian trial also tests the other live argument in knee replacement, which is how the new knee should be lined up.
What the studies looked at
RACER-Knee is the largest masked trial of a robotic knee system yet published. Across ten NHS hospitals in England, Scotland and Wales, 33 surgeons randomised 339 patients with knee osteoarthritis to a knee replacement done either with the Mako robotic arm or with conventional instruments. The same implant was used in both groups. Patients did not know which they had received: everyone had the same draping, the same small skin incisions (real pin sites for the robot, sham cuts for the conventional group), and a masked operation note. The main outcome was the Forgotten Joint Score at 12 months, a 0 to 100 questionnaire that asks how often you are aware of your artificial knee in daily life, where a higher score means you forget it more. The trial was designed to detect a 12-point difference, roughly one point on each of its twelve questions, and it also costed both operations for the NHS.
RASKAL was run through the Australian joint replacement registry, at nine private and two public hospitals, by 14 surgeons. It randomised 303 patients twice over. First, to surgery with the same Mako robot or with computer navigation, the older, cheaper technology that guides the surgeon’s cuts without a robotic arm. Second, to one of two alignment philosophies. Mechanical alignment aims for a straight leg with the implant set square to the long axis of the bones, and has been the standard for decades. Functional alignment instead restores something close to the patient’s own natural alignment, within safe limits, and uses the technology’s measurements to balance the ligaments with as little cutting of soft tissue as possible. The main outcome was the change in the KOOS-12, a 0 to 100 knee pain-and-function questionnaire, over two years.
What they found
- Patient outcome, RACER-Knee: no difference. At 12 months the Forgotten Joint Score averaged 49.2 with the robot and 50.2 without it. The adjusted difference was 1.5 points in favour of conventional surgery (95% CI −7.5 to 4.5), and the confidence interval excludes the 12-point difference the trial was looking for. Pain in the first three days, opioid use, time to discharge, the Oxford Knee Score and quality of life were all the same in both groups.
- Patient outcome, RASKAL: no difference either. Over two years the KOOS-12 improved by a similar amount whether the surgeon used the robot or navigation (difference 2.8 points favouring navigation, 95% CI −6.4 to 0.9), and no secondary measure, including satisfaction, separated the groups at any time point.
- Alignment philosophy: no difference in how the knee felt, but a real difference in how the operation went. Functional and mechanical alignment produced the same two-year scores (difference 0.3 points, 95% CI −3.4 to 4.0). Mechanically aligned knees, though, needed a soft-tissue release to get the ligaments balanced in 45% of cases, against 8% for functional alignment.
- The robot did what it is designed to do. In RACER-Knee the implant ended up 0.8 degrees closer to the plan on average (95% CI 0.3 to 1.4), a precision gain that matches the 2023 review. In RASKAL the robot also shortened the operation by 11.5 minutes compared with navigation and caused less visible damage to the posterior cruciate ligament, a structure that the functional-alignment technique keeps. In RACER-Knee the robotic operation took 10.5 minutes longer than conventional instruments. The two findings are not in conflict: the robot is quicker than navigation and slower than a surgeon with jigs.
- Cost. In the NHS, the robotic admission cost £995 more per patient. Over the first year the extra spend bought no measurable gain in quality of life, and the chance that robotic surgery was cost-effective at the usual NHS threshold was about 4%.
- Safety. Serious adverse events were identical in RACER-Knee, 16 in each group. There were three deep infections with the robot and one without, numbers too small to mean anything on their own but worth watching in registry data. In RASKAL one patient in the robotic group fractured the bone through a pin site and needed it fixed, and the only two revisions were both in the navigated mechanical-alignment group.
- One telling aside. RACER-Knee asked patients which operation they thought they had received. Those who believed they had the robot reported a much higher Forgotten Joint Score than those who believed they had conventional surgery, regardless of what had actually been done. That is an exploratory finding, not a result, but it shows why masking patients in a trial like this matters, and why unmasked comparisons of robotic surgery should be read with care.
- What the surgeons thought. After each RASKAL operation, surgeons said they would have preferred the robot 82% of the time and functional alignment 73% of the time. They liked using them. The knees did not know the difference.
What it means for you
The picture has not changed since September, but it now rests on far stronger evidence. Robotic assistance places the implant closer to the plan, more consistently, than a surgeon working with jigs. What it has not been shown to do, in two well-run randomised trials on top of the earlier meta-analysis, is make the knee feel or work better for the patient in the first one to two years. That is exactly why this practice describes robotic assistance as a tool used where it adds value, rather than as something that by itself produces a better result.
On alignment, the honest position is that either philosophy, done well, gives the same result at two years. Functional alignment gets there with far less soft-tissue release, which is a reasonable thing for a surgeon to want. It is not, on this evidence, a reason for a patient to insist on one approach over the other.
None of this makes robotic surgery a bad idea. A shorter operation than navigation, less handling of the ligaments and tighter precision are real advantages in the operating theatre, and they may matter more in particular knees than they do on average. It does mean that if you are weighing up a robotic against a conventional knee replacement, “more accurate” and “better outcome” are still two different claims. The first is established. The second is not, and the evidence that it is not is now good.
A caveat worth knowing
Both trials report early results. RACER-Knee is following its patients for ten years and RASKAL sits inside the national registry, so the question that matters most over time, whether precision translates into fewer revisions, will be answered by these same patients, but not yet. Both trials studied one robot and one implant, so they say nothing about other systems. RASKAL compared the robot with navigation rather than with plain instruments, and its functional alignment was a restricted version that kept every knee within set limits, not the unrestricted kinematic technique some surgeons use. Both trials also excluded the knees where technology might plausibly earn its keep: severe deformity, previous fracture, complex implants. And each was designed to detect a moderate difference, so a small benefit, or a benefit in a particular group of patients, has not been ruled out. For now the finding is consistent across every randomised comparison available: more precise, yes; a better knee for the patient, not shown.