, Volume 471, Issue 2, pp 393-402
Date: 16 Oct 2012

The 2012 John Charnley Award: Clinical Multicenter Studies of the Wear Performance of Highly Crosslinked Remelted Polyethylene in THA

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Abstract

Background

Highly crosslinked polyethylene (HXLPE) in THA was developed to reduce particle-induced periprosthetic osteolysis. A series of clinical studies were initiated to determine the clinical efficacy as judged by patient-reported scores, radiographic osteolysis, and wear analysis of one form of HXLPE.

Questions/purposes

The purposes of this series of studies were to (1) determine the wear rates of one form of HXLPE; (2) report long-term (7–10 years) patient-reported outcome measures; (3) assess the effect of femoral head size on wear; and (4) determine the incidence of periprosthetic osteolysis.

Methods

A single-center and two multicenter studies were conducted on 768 primary patients (head size 26–36 mm) undergoing THA at eight medical centers. Patient-reported outcome scores, radiographic grading for osteolysis, and radiographic wear evaluation were performed.

Results

Serial plain radiographs showed no periprosthetic osteolysis in the three studies. The average femoral head penetration rates did not correlate with time in vivo for patients with standard femoral head sizes. Although there was an indication of higher wear in patients with 36-mm diameter femoral heads, it was below the threshold for producing osteolysis.

Conclusions

The introduction of this HXLPE substantially improved the prognosis of patients after THA up to 13 years as judged by clinical scores, incidence of osteolysis, and polyethylene wear measurements.

Level of Evidence

Level III, therapeutic study. See the Guideline for Authors for a complete description of levels of evidence.

Multicenter Study Group: Harry E. Rubash MD, Young-Min Kwon MD, PhD, John Clohisy MD, Richard White MD, Craig Della Valle MD, Daniel Berry MD, Paul F. Lachiewicz MD, Kim Bertin MD, Per-Erik Johanson MD, William H. Harris MD
H. E. Rubash, Y.-M. Kim, W. H. Harris
Massachusetts General Hospital, Boston, MA, USA
J. Clohisy
Washington University in St Louis, St Louis, MO, USA
R. White
Presbyterian Hospital, Albuquerque, NM, USA
C. Della Valle
Rush University Medical Center, Chicago, IL, USA
D. Berry
Mayo Medical School, Rochester, MN, USA
P. F. Lachiewicz
Chapel Hill Orthopedic Surgery and Sports Medicine, Chapel Hill, NC, USA
K. Bertin
Utah Bone & Joint Center, Salt Lake City, UT, USA
P.-E. Johanson
Sahlgrenska University Hospital, Gothenburg, Sweden
One of the authors (CDV) certifies he has or may receive payments or benefits, in any one year, an amount in excess of $10,000 from a commercial entity (Biomet, Warsaw, IN, USA, and Smith & Nephew, Memphis TN, USA). One of the authors (KB) certifies that he has or may receive payments or benefits, during the study period, an amount of more than $1,000,001 from Zimmer Inc (Warsaw, IN, USA) and DePuy Ortho Inc (Warsaw, IN, USA). One of the authors (DB) certifies that he has or may receive payments or benefits, during the study period, an amount of more than $1,000,001 from DePuy Ortho Inc. The institution of two contributors (PL, DB) receives research funds From (DePuy Ortho Inc or Zimmer Inc). The institution of one or more of the authors (CRB, MD, BJ, YMK, HM, PEJ, DB, JC) received funding from Zimmer Inc, Curing Hip Disease Fund, DePuy, and/or the William H. Harris Foundation. Seven contributors (JC, MD, YMK, BJ, PEJ, HP, HM) certifies that he or she, or a member of their immediate family, has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.
All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request.
Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use.
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 was obtained if needed.
This work was performed at The Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA USA.