Comparative Safety and Efficacy of Patient-Specific Versus Hand-Molded Implants in Cranioplasty: A Systematic Review and Meta-Analysis.

Background/

Objectives

Cranioplasty (CP) is associated with high complication rates (20-50%), and the optimal choice between patient-specific implants (PSIs) and hand-molded (HM) alternatives remains debated. This systematic review and meta-analysis aims to compare surgical and postoperative outcomes between PSIs and HM implants.

Methods

A systematic search was performed in three databases to identify studies reporting surgical site infection (SSI), implant removal, reoperation, operative time or cosmetic outcome for PSIs and/or HM implants. Two-arm studies of the same material were analyzed separately from pooled single- and two-arm studies.

Results

125 observational studies involving 10,034 patients were included. In two-arm comparisons, PSIs reduced implant removal for titanium (OR 0.34, p = 0.053) and PMMA (OR 0.56, p = 0.188), while SSI rates showed no meaningful difference between groups. In one-arm analyses, PSIs demonstrated lower explantation probabilities (titanium 6.1%, PMMA 7.9%) compared with HM alternatives (titanium 9.9%, PMMA 14.2%), alongside shorter operation times and fewer reoperations. Cosmetic outcomes consistently favored PSIs.

Conclusions

PSIs demonstrate advantages in efficiency, durability, and esthetics compared with HM implants, supporting their preferential use where resources allow. HM implants remain a cost-effective option in resource-limited settings. Due to the observational nature of the included studies and differences in study populations across arms, the findings should be interpreted with caution.