The study
This was a pilot randomised study in adults with plantar fasciitis, comparing two ways of making a custom orthotic. Thirty-four people were assigned to either traditionally fabricated custom orthoses (18 people) or HP Arize 3D-printed orthoses (16 people), made from a digital scan and additive printing. It was a small, early pilot, designed to explore whether the two approaches are in the same ballpark, not to deliver a definitive verdict.
On conflicts, read the disclosure statement rather than assuming. The paper does not declare industry funding for the trial itself, and the authors' listed commercial relationships are with other orthopaedic companies rather than with HP. The study does test a named commercial platform, so a degree of caution is still sensible, but it would be wrong to write this off as a manufacturer-funded study.
They measured patient satisfaction, function over the early weeks of wear using PROMIS scores, compliance with actually wearing the devices, and any adverse effects.
What they found
Both groups did well. Patients in both reported high satisfaction and functional improvement, which is reassuring for the basic question of whether 3D-printed devices can do the job at all.
A couple of differences showed up in exploratory analysis, and the word exploratory matters, because in a small pilot these are signals rather than firm conclusions. At eight weeks the traditional group scored higher on PROMIS physical function (49.0 against 41.9) and mobility (46.9 against 41.4), and they reported greater daily use. Pain interference did not differ. The traditional devices also drew more complaints of rubbing and discomfort at four weeks, though by eight weeks the difference in side effects was no longer significant.
What it means for your practice
This is a good discussion point for any clinic thinking about how it makes orthoses. 3D printing is genuinely promising and clearly capable of producing devices that satisfy patients and improve function, but this study does not show it is better than a well-made traditional custom device. The differences were small, early, and from a pilot that was explicitly designed to estimate effect sizes for a future trial rather than to settle the question.
If you are investing in 3D printing, or marketing it, the credible position is to be enthusiastic and accurate at the same time. The technology brings real advantages in consistency and scalability, and the early outcomes look fine, but it is not yet a clinical upgrade over a good traditional device, and it would be overreaching to tell patients otherwise. Equally, if you make traditional custom orthoses well, this is not a reason to feel behind.
For most clinics the practical takeaway is that you can adopt 3D printing for its workflow and scalability benefits with reasonable confidence in the outcomes, while keeping your claims about superiority modest until larger, independent studies arrive.
Bottom line
3D-printed custom orthoses performed comparably to traditional ones for plantar fasciitis in this small pilot, with high satisfaction in both and only small, early differences. It is a promising, scalable option, but not yet a proven step up from a well-fitted traditional device.