Abstract
INTRODUCTION
Additive manufacturing (3D printing) is used to create porous surfaces that promote bone ingrowth in an effort to improve initial stability and optimize long-term biological fixation. The acetabular cup that was studied is manufactured with titanium alloy powder via electron beam melting. Electron beam melting integrates the porous and solid substrate rather than sintering a porous coating to a solid surface. The 3D-printed acetabular cup's high surface coefficient of friction (up to 1.2), combined with its geometry, creates a predictable press-fit in the acetabulum, improving initial mechanical stability and ultimately leading to reproducible biologic fixation. The objective of this study was to evaluate the early clinical outcomes and implant fixation of this 3D-printed acetabular cup in total hip arthroplasty (THA).
METHODS
Four hundred twenty-eight subjects from 8 US and international research sites underwent primary THA with the 3D-printed acetabular cup. All sites received IRB approval prior to conducting the study, and all participants signed the informed consent. Screw usage and number used during surgery were used as a surrogate measurement for initial implant fixation. Clinical performance outcomes included pre- and post-operative Harris Hip Scores (HHS) and Oxford Hip Scores (OHS), patient satisfaction, and revision assessment. 215 patients had a minimum 1-year post-operative follow-up visit.
Student t-tests were used to identify significant mean differences (p<0.05).
RESULTS
Acetabular screws were used in 206 of 428 cases (48.1%); 85.9% used 1 screw, 12.6% used 2 screws, and 1.5% used 3 screws. For patients with a 1-year post-operative visit, the HHS improved by 49.8 points to 91.9 from 42.1, and the OHS improved by 27.7 points to 44.4 from16.7. Patient satisfaction scores at the 1-year post-operative visit were 9.7±0.7 (n=94). There was no significant difference between genders with regard to BMI, the 1-year post-operative HHS, OHS, or patient satisfaction scores. However, the males were significantly younger (59.8 vs. 62.9 years) and had significantly higher pre-operative HHS (45.7 vs. 37.9) and OHS scores (17.8 vs. 15.3). There were 9 revisions reported.
DISCUSSION
For initial implant fixation, compared to a similar, non-3D-printed acetabular cup in the same product line, the 3D-printed cup used significantly fewer screws per case (n=1 for 85.9% cases vs. n=2 for 85.7% of cases) in a fewer percentage of cases (48.1% vs. 70.4%), suggesting greater initial stability and “scratch fit”. The 3D-printed acetabular cup also displayed positive early clinical results as evidenced by the pronounced improvement in clinical outcome scores from the pre-operative visit to the 1-year post-operative visit. These 1-year improvements are better than moderate clinically important improvements reported in the literature (40.1 points for HHS). Patient satisfaction scores were also excellent (9.7/10). There were nine revisions; however, four of these were due to patient falls and one was due to infection.
SIGNIFICANCE
The 3D-printed acetabular cup evaluated in this study demonstrated improved implant fixation and positive early clinical outcomes for THA.
