Pilot, Randomized Comparison of Traditionally Fabricated Custom Foot Orthoses vs HP Arize 3D-Printed Orthoses for...

Plantar fasciitis is the most common cause of plantar heel pain and the use of custom foot orthosis is a well-supported treatment modality. Traditional custom orthoses are fabricated using foam impressions and manual techniques, but these methods are time-intensive and susceptible to variability in fit and quality. The HP Arize platform applies high-resolution 3D laser scanning with algorithm-driven modeling to streamline fabrication of custom foot orthoses. Although early reports suggest comparable comfort and durability to traditional devices, clinical data evaluating patient-reported outcomes remain limited.

This prospective pilot, randomized study assigned 34 adults diagnosed with plantar fasciitis to receive either traditionally fabricated custom orthoses (n = 18) or HP Arize 3D-printed orthoses (n = 16). Primary analyses used a modified intention‑to‑treat cohort (n = 30) comprising participants who received an insert and completed baseline assessments. Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, pain interference, and mobility scores were collected at baseline, 4 weeks, and 8 weeks. Secondary measures included patient satisfaction, frequency of orthotic use, and adverse effects. Statistical comparisons were performed using Fisher exact test and Student t test or Wilcoxon signed-rank test, with significance set at P < .05.

Baseline demographic and clinical characteristics did not differ between groups. At 4 weeks, satisfaction with customization, fit, and comfort was high across both groups (median 4.0-5.0). Traditional orthosis users reported greater daily use (P = .04) but also higher rates of rubbing/discomfort (P = .047). By 8 weeks, side effects were not statistically significantly different. Exploratory comparisons suggested higher mean PROMIS physical function (49.0 vs 41.9, Δ 7.1; P = .008) and mobility scores (46.9 vs 41.4, Δ 5.5; P = .02) at 8 weeks in the traditional group, whereas pain interference scores did not differ.

Both traditionally fabricated and HP Arize 3D-printed custom orthoses were associated with high satisfaction and functional improvement. Although traditional devices showed greater early compliance and superior 8-week functional outcomes, the HP Arize system demonstrated fewer adverse effects and offers a scalable, efficient alternative. As an exploratory pilot study, these findings are preliminary and intended to inform feasibility and effect‑size estimation for future trials.

Level IV, pilot prospective comparative study.

Quasi-experimental pre-post study.