Radial head replacement with the 3D-printed patient-specific titanium prosthesis: Preliminary results of a multi-centric prospective study.

Purpose: To report preliminary clinical results and safety of 3D-printed patient-specific titanium radial head (RH) prosthesis in treatment of the irreparable RH fractures.

Material and methods: This multi-centric prospective study included 10 patients (6 men and four women, mean age 41 years (range, 25-64 years)). Three cases were classified as Mason type III and 7 cases as type IV. Patients were assessed preoperatively, intraoperatively, and at 1, 6, 12, 24, 36, and 48 weeks postoperatively. Range of motion (ROM), visual analog scale (VAS) score, Disabilities of the Arm, Shoulder and Hand (DASH) score, Mayo Elbow Performance Score (MEPS), radiology imaging, and laboratory blood and urine testing were evaluated.

Results: The prostheses were implanted utilizing cemented stems in 5 patients and cementless stems in 5 patients. Intraoperatively, well congruency of a prosthesis with capitellum and radial notch of ulna was observed in all cases. All patients had improvement of ROM, VAS score, DASH score, and MEPS during the postoperative follow-ups. At the final follow-up, mean elbow extension was 6.5° (range, 0°-30°), flexion 145° (range, 125°-150°), supination 79° (range, 70°-80°), and pronation 73.5° (range, 45°-80°). Mean VAS score was 0.3 (range, 0-3), DASH score was 12.35 (range, 1.7-23.3), and MEPS was 99.5 (range, 95-100). Postoperative radiographs demonstrated heterotopic ossification in 2 cases, periprosthetic radiolucency in 2 cases, and proximal radial neck resorption in 2 cases. No one had the evidence of capitellar erosion, implant failure, malpositioning, overstuffing, or symptomatic stem loosening. There was no significant alteration of laboratory results or adverse events related to the 3D-printed prosthesis implantation.

Conclusion: The preliminary results demonstrated that implantation of the 3D-printed patient-specific titanium RH prosthesis is safe and may be a potential treatment option for irreparable RH fracture.