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Delta Ceramic-on-Alumina Ceramic Articulation in Primary THA: Prospective, Randomized FDA-IDE Study and Retrieval Analysis

  • Symposium: Papers Presented at the Hip Society Meetings 2009
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

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.

Level of Evidence: Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

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Acknowledgments

We thank Tom Donaldson, MD, and Koseki Kubo, MD, PhD, for their assistance in analysis of the delta head fracture. We also thank Tawnya L. Tucker, MT, for her assistance with the collection of data in this study.

Author information

Authors and Affiliations

  1. Joint Implant Surgeons, Inc, 7277 Smith’s Mill Road, Suite 200, New Albany, OH, 43054, USA

    Adolph V. Lombardi Jr. MD, Keith R. Berend MD, Brian E. Seng DO & Joanne B. Adams BFA

  2. Department of Orthopaedics, The Ohio State University, Columbus, OH, USA

    Adolph V. Lombardi Jr. MD & Keith R. Berend MD

  3. Mount Carmel Health System, New Albany, OH, USA

    Adolph V. Lombardi Jr. MD & Keith R. Berend MD

  4. Department of Biomedical Engineering, The Ohio State University, Columbus, OH, USA

    Adolph V. Lombardi Jr. MD

  5. Peterson Research Center at Loma Linda University and Donaldson Arthritis Research Foundation, Loma Linda, CA, USA

    Ian C. Clarke PhD

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  1. Adolph V. Lombardi Jr. MD
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  2. Keith R. Berend MD
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  3. Brian E. Seng DO
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Corresponding author

Correspondence to Adolph V. Lombardi Jr. MD.

Additional information

One or more of the authors (AVL, KRB) receive royalties and institutional research support from and have consulting agreements with Biomet, Inc (Warsaw, IN). One author (KRB) has consulting agreements with Synvasive Technology, Inc (El Dorado Hills, CA) and Salient Surgical Technologies (Portsmouth, NH) and owns stock in Angiotech Pharmaceuticals, Inc (Vancouver, BC). One author (AVL) receives royalties from Innomed, Inc (Savannah, GA).

Each author certifies that his or her institution has approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

This work was performed at Joint Implant Surgeons, Inc.

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Lombardi, A.V., Berend, K.R., Seng, B.E. et al. Delta Ceramic-on-Alumina Ceramic Articulation in Primary THA: Prospective, Randomized FDA-IDE Study and Retrieval Analysis. Clin Orthop Relat Res 468, 367–374 (2010). https://doi.org/10.1007/s11999-009-1143-9

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  • DOI: https://doi.org/10.1007/s11999-009-1143-9

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