Delta ceramic-on-alumina ceramic articulation in primary THA: prospective, randomized FDA-IDE study and retrieval analysis.
Wear and osteolysis continue to be major reasons for revision surgery in THA. Ceramic-on-ceramic bearings eliminate polyethylene wear debris. The newest generation of these bearings incorporate nanosized, yttria-stabilized tetragonal zirconia particles producing an alumina matrix composite. We asked whether this new material would perform as well as a conventional bearing in terms of functional hip scores, radiographic migration and osteolysis, complications and survival. As part of a US FDA investigational device exemption study (G000075), we conducted an initial prospective safety study of 21 alumina matrix composite femoral heads articulating on alumina liners followed by a prospective, randomized study with 44 more of these articulations and 45 zirconia femoral heads on polyethylene liners. The minimum followup for all patients was 26 months (mean, 73 months; range, 26-108 months). Harris hip scores and radiographic findings were similar in the two groups as was survivorship (trial 95% versus control 93%). There were three reoperations in the trial group and three in the control group. A fractured head retrieval showed a 33% monoclinic transformation with an increase in surface roughness from 3 to 5 nm at the main wear zone. While our numbers were insufficient to compare device-related complications, the trial device performed as well as the control device in terms of reoperation, and clinical and radiographic outcome. The alumina matrix composite femoral head on an alumina liner provided high survivorship.


METHODS
Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
Lombardi
Adolph V
AV
Joint Implant Surgeons, Inc, 7277 Smith's Mill Road, Suite 200, New Albany, OH 43054, USA. lombardiav@joint-surgeons.com
Berend
Keith R
KR
Seng
Brian E
BE
Clarke
Ian C
IC
Adams
Joanne B
JB
D000328:Adult; D000368:Aged; D000537:Aluminum Oxide; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006621:Hip Joint / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006622:Hip Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010014:Osteolysis / Q000209:etiology; D020959:Polyethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011859:Radiography; D020127:Recovery of Function; D012086:Reoperation; D013314:Stress, Mechanical; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D015019:Yttrium; D015040:Zirconium
C499362:yttria stabilized tetragonal zirconia; D015019:Yttrium; D020959:Polyethylene; D015040:Zirconium; D000537:Aluminum Oxide