The Journal of Bone and Joint Surgery (American). 2007;89:367-375.
doi:10.2106/JBJS.F.00148
© 2007 The Journal of Bone and Joint Surgery, Inc.
Failure Analysis of a Ceramic Bearing Acetabular Component
Robert A. Poggie, PhD1,
Thomas R. Turgeon, BSc, MD2 and
Richard D. Coutts, MD3
1 Zimmer Trabecular Metal Technology, 48 Horsehill Road, Cedar Knolls, NJ 07927.
E-mail address:
bob.poggie{at}zimmer.com
2 Concordia Hospital, N1S-119, 1095 Concordia Avenue, Winnipeg, MB R2K 3S8,
Canada. E-mail address:
tturgeon{at}concordiahospital.mb.ca
3 University of California San Diego, 8008 Frost Street, Suite 300, San Diego,
CA 92123. E-mail address:
rdcoutts{at}aol.com
Investigation performed at Zimmer Trabecular Metal Technology, Inc.,
Parsippany, New Jersey, and Malcolm and Dorothy Coutts Institute for Joint
Reconstruction and Research, San Diego, California
Disclosure: The authors did not receive any outside funding or
grants in support of their research for or preparation of this work. One or
more of the authors, or a member of his or her immediate family, received, in
any one year, payments or other benefits in excess of $10,000 or a commitment
or agreement to provide such benefits from a commercial entity (Implex
Corporation and Zimmer Incorporated [employee]). No commercial entity paid or
directed, or agreed to pay or direct, any benefits to any research fund,
foundation, division, center, clinical practice, or other charitable or
nonprofit organization with which the authors, or a member of their immediate
families, are affiliated or associated.
Background: Alternative bearings have been explored in an attempt to
improve the longevity of total hip prostheses. A Food and Drug Administration
(FDA)-approved clinical study of a nonmodular acetabular component consisting
of a porous metal shell, compression-molded polyethylene, and a ceramic liner
inlay was discontinued following reports of early failures.
Methods: Between October 1999 and January 2003, 429 patients were
enrolled in a prospective study to evaluate a cementless ceramic-on-ceramic
total hip arthroplasty design (Hedrocel ceramic bearing cup; Implex,
Allendale, New Jersey). Two hundred and eighty-two patients (315 hips) were
treated with the experimental acetabular implant and 147 patients (157 hips)
were treated with an acetabular implant that consisted of the same porous
shell but an allpolyethylene liner. Clinical data including a Harris hip score
and responses to the Short Form-12 (SF-12) health survey were collected
preoperatively and at twelve and twenty-four months postoperatively. Serial
radiographs were made preoperatively; at six weeks, three months, six months,
and twelve months postoperatively; and annually thereafter. Retrieval analysis
was performed on all failed explanted components. Failure was defined as
fracture or displacement of the ceramic liner out of the acetabular component.
In addition, biomechanical testing was performed on unimplanted acetabular
components and mechanically altered cups in an effort to recreate the
mechanisms of failure. Finite element analysis was used to estimate stress and
strain within the ceramic liner under extreme physiologic loading
conditions.
Results: The ceramic liner failed in fourteen of the 315
experimental acetabular components; all of the failures were at the
ceramic-polyethylene interface. Patients with a body weight of >91 kg had a
4.76 times greater odds of the ceramic liner failing than those who weighed
91 kg. Retrieval analysis demonstrated stripe and rim wear with evidence
of adhesive wear, indicating a potentially high-friction interaction at the
articulation. Finite element analysis demonstrated that the forces on the
ceramic liner in cups subjected to extreme loading conditions were
insufficient to cause fracture. Biomechanical testing was unable to reproduce
an initial ceramic liner displacement in vitro; however, when the ceramic
liner was forcibly displaced prior to biomechanical testing, complete
displacement and eventual fracture of the ceramic liner resulted.
Conclusions: We hypothesized that the combination of a high patient
body weight, an extensive range of motion, and subluxation of the femoral head
led to high friction at the articulation between the femoral head and the rim
of the liner, which initiated displacement of the ceramic liner. Subsequent
normal gait led to further displacement of the liner in all of the fourteen
failed components and eventually to ceramic fracture in twelve of the fourteen
components.
Level of Evidence: Prognostic Level I. See Instructions
to Authors for a complete description of levels of evidence.

CiteULike Connotea Del.icio.us Technorati What's this?
|