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Is There Material Loss at the Backside Taper in Modular CoCr Acetabular Liners?

  • Basic Research
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

Metal wear and corrosion products generated by hip replacements have been linked to adverse local tissue reactions. Recent investigations of the stem/head taper junction have identified this modular interface as another possible source of metal debris; however, little is known regarding other modular metallic interfaces, their ability to produce metal debris, and possibly to provide insight in the mechanisms that produce metal debris.

Questions/purposes

We asked three questions: (1) can we develop a reliable method to estimate volumetric material loss from the backside taper of modular metal-on-metal liners, (2) do backside tapers of modular metal-on-metal liners show a quantifiable volumetric material loss, and, if so, (3) how do regions of quantitatively identified material loss correspond to visual and microscopic investigations of surface damage?

Methods

Twenty-one cobalt-chromium (CoCr) liners of one design and manufacturer were collected through an institutional review board-approved retrieval program. All liners were collected during revision surgeries, where the primary revision reason was loosening (n = 11). A roundness machine measured 144 axial profiles equally spaced about the circumference of the taper region near the rim to estimate volume and depth of material loss. Sensitivity and repeatability analyses were performed. Additionally, visual and scanning electron microscopy investigations were done for three liners.

Results

Our measurement method was found to be reproducible. The sensitivity (how dependent measurement results are on experimental parameters) and repeatability (how consistent results are between measurements) analyses confirmed that component alignment had no apparent effect (weak correlation, R2 = 0.04) on estimated volumetric material loss calculations. Liners were shown to have a quantifiable material loss (maximum = 1.7 mm3). Visual investigations of the liner surface could identify pristine surfaces as as-manufactured regions, but could misidentify discoloration as a possible region of material loss. Scanning electron microscopy more accurately distinguished between as-manufactured and damaged regions of the taper.

Conclusions

The roundness machine has been used to develop a repeatable method for characterizing material loss; future work comparing a gravimetric standard with estimations of material loss determined from the roundness machine may show the accuracy and effectiveness of this method. Liners show rates of material loss that compare with those reported for other taper junctions. Visual inspection alone may misidentify as-manufactured regions as regions of material loss.

Clinical relevance

This study identifies the acetabular liner/shell interface in modular metal-on-metal devices as a potential source of metal wear or corrosion products. The relation between metal debris and clinical performance, regardless of the type of bearing couple, is a concern for clinicians. Therefore, it is important to characterize every type of modular junction to understand the quantity, location, and mechanism(s) of material loss.

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Author information

Authors and Affiliations

  1. Department of Materials Science and Engineering, Drexel University, Philadelphia, PA, 19104, USA

    Matthias T. Agne

  2. Biomedical Engineering Practice, Exponent, Inc, Philadelphia, PA, USA

    Richard J. Underwood PhD, Judd S. Day PhD & Steven M. Kurtz PhD

  3. Department of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA, USA

    Richard J. Underwood PhD, Sevi B. Kocagoz BS, Daniel W. MacDonald MS, Judd S. Day PhD & Steven M. Kurtz PhD

  4. Department of Orthopaedic Surgery, Rothman Institute, Philadelphia, PA, USA

    Javad Parvizi MD

  5. Department of Orthopaedic Surgery, University Hospitals Case Medical Center, Cleveland, OH, USA

    Matthew J. Kraay MS, MD

  6. Department of Orthopaedic Surgery, Rubin Institute for Advanced Orthopaedics, Baltimore, MD, USA

    Michael A. Mont MD

  7. Department of Orthopaedic Surgery, Hartzband Center for Hip and Knee Replacement, Paramus, NJ, USA

    Gregg R. Klein MD

  8. Department of Orthopaedic Surgery, Tennessee Orthopedic Clinics, Knoxville, TN, USA

    Harold E. Cates MD

Authors
  1. Matthias T. Agne
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  2. Richard J. Underwood PhD
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  3. Sevi B. Kocagoz BS
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  4. Daniel W. MacDonald MS
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  5. Judd S. Day PhD
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  6. Javad Parvizi MD
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  7. Matthew J. Kraay MS, MD
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  8. Michael A. Mont MD
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  9. Gregg R. Klein MD
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  11. Steven M. Kurtz PhD
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Corresponding author

Correspondence to Matthias T. Agne.

Additional information

Institutional funding has been received from the National Institutes of Health (NIAMS) R01 AR47904 (MA, RU, SK, DM, JD, SMK); CeramTec (Plochingen, Germany) (MA, RU, SK, DM, JD, SMK, JP); Stryker Orthopaedics (Mahwah, NJ, USA) (MA, RU, SK, DM, JD, SMK, JP, MM); Zimmer, Inc (Warsaw, IN, USA) (MA, RU, SK, DM, JD, SMK, JP, GK, HC); Celanese (Florence, KY, USA) (MA, RU, SK, DM, JD, SMK); Formae (Paoli, PA, USA) (MA, RU, SK, DM, JD, SMK); Invibio (Lancashire, UK) (MA, RU, SK, DM, JD, SMK); Stelkast (McMurray, PA, USA) (MA, RU, SK, DM, JD, SMK, JP); Aesculap/B.Braun (Center Valley, PA, USA) (MA, RU, SK, DM, JD, SMK); Biomet (Warsaw, IN, USA) (RU, JD, SMK); DePuy Synthes (Warsaw, IN, USA) (RU, JD, SMK, JP); Medtronic (Minneapolis, MN, USA) (RU, JD, SMK); Kyocera Medical (Yodogawa-ku, Osaka, Japan) (RU, JD, SMK); Wright Medical Technology (Arlington, TN, USA) (RU, JD, SMK, MM); DJO (Vista, CA, USA) (RU, JD, SMK, MM); Active Implants (Memphis, TN, USA) (RU, JD, SMK); Smith & Nephew (Memphis, TN, USA) (RU, JD, SMK, JP, HC); Spinal Motion (Mountain View, CA, USA) (RU, JD, SMK); 3 M (Saint Paul, MN, USA) (JP); Joint Active Systems (Effingham, IL, USA) (MM).

One of the authors certifies that he (JP) has received or may receive payments or benefits, during the study period, an amount of USD 10,000 to 100,000 from Smith & Nephew (Memphis, TN, USA) an amount of USD 10,000 to 100,000 from 3 M (Saint Paul, MN, USA), an amount of USD 10,000 to 100,000 from Cadence Pharmaceuticals, Inc (San Diego, CA, USA), an amount of USD 10,000 to 100,000 from CeramTec (Laurens, SC, USA), an amount of USD 10,000 to 100,000 from Pfizer (New York, NY, USA), an amount of USD 10,000 to 100,000 from Salient Surgical (Minneapolis, MN, USA), an amount of USD 10,000 to 100,000 from TissueGene (Rockville, MD, USA), and an amount of USD 10,000 to 100,000 from Zimmer Inc (Warsaw, IN, USA).

One of the authors certifies that he (MM) has received or may receive payments, during the study period, an amount of USD 100,000 to USD 1,000,000 from Stryker Orthopaedics (Mahwah, NJ, USA), an amount of USD 10,000 to USD 100,000 from DJ Orthopaedics (Vista, CA, USA), an amount of USD 10,000 to USD 100,000 from Medical Compression Systems (West Hills, CA, USA), an amount of USD 10,000 to USD 100,000 from Sage Products LLC (Cary, IL, USA), and an amount of USD 10,000 to USD 100,000 from TissueGene (Rockville, MD, USA).

One of the authors certifies that he (GK) has received or may receive payments, during the study period, an amount of USD 10,000 to USD 100,000 from Zimmer, Inc (Warsaw, IN, USA).

One of the authors certifies that he (HC) has received or may receive payments, during the study period, an amount of USD 10,000 to USD 100,000 from Zimmer, Inc (Warsaw, IN, USA), an amount of USD 10,000 to USD 100,000 from Zimmer, Inc (Warsaw, IN, USA), an amount of USD 10,000 to USD 100,000 from Stryker Orthopaedics (Mahwah, NJ, USA), an amount of USD 10,000 to USD 100,000 from Smith & Nephew (Memphis, TN, USA).

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.

Each author certifies that his or her institution 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.

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.

This work was performed at the Implant Research Center, Drexel University, Philadelphia, PA, USA.

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Agne, M.T., Underwood, R.J., Kocagoz, S.B. et al. Is There Material Loss at the Backside Taper in Modular CoCr Acetabular Liners?. Clin Orthop Relat Res 473, 275–285 (2015). https://doi.org/10.1007/s11999-014-3982-2

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