Aetna considers Food and Drug Administration-approved metal-on-metal or ceramic-on-ceramic total hip replacement prostheses medically necessary for total hip arthroplasty (see Appendix for selection criteria).
Previously, most total hip prostheses utilize an acetabular cup either lined with polyethylene or composed entirely of polyethylene articulating against a cobalt-chromium-molybdenum (CoCr) or ceramic femoral head. Serious problems affecting the outcome of total joint replacement with these types of prostheses have been extensive and progressive peri-prosthetic osteolysis and aseptic loosening, which may result in revision, even though the components are still well fixed and functioning. Polyethylene particulate debris generated from metal-on-polyethylene bearing surfaces and the resulting biologic response to this debris are thought to be largely responsible.
In recent years, there has been renewed interest in metal-on-metal bearing surfaces for total joint arthroplasty. This is especially true in younger and more active patients who face the possibility of multiple revision procedures during their lifetime. In the long-term, the second-generation all-metal prostheses have demonstrated lower friction and wear rates than metal-on-polyethylene bearing surfaces. Recent studies reported that the second-generation metal-on-metal hip replacement prostheses exhibit a lower rate of acetabular revision and loosening than did those with previous metal-on-metal designs and that they had no more acetabular loosening or osteolysis than did those with metal-on-polyethylene articulations for follow-up periods of 5 to 10 years.
Another alternative to standard polyethylene is alumina-on-alumina ceramic. When comparing hard-on-hard bearings, the ceramic-on-ceramic coupling has several theoretical advantages over metal-on-metal. Because of the ceramic's extremely low coefficient of friction and its potential for superior wear resistance, these couples promise both wear rates that are appreciably less than polyethylene-on-metal and metal-on-metal couples.
Available literature indicates that alumina-on-alumina ceramic couplings are a viable alternative to metal-on-polyethylene designs. The combination of new high quality ceramic acetabular and femoral bearing heads with hip systems that have achieved long-term stable fixation can result in a substantial increase in the longevity of fixation for implants especially in the younger and more active patients.
Available studies of metal-on-metal and ceramic-on-ceramic total hip implants primarily involve cohorts of younger, more active patients. The chief advantage of these hip implants over standard metal-on-polyethylene hip implants is their greater longevity. There is no adequate evidence that metal-on-metal or ceramic-on-ceramic total hip implants offer clinically significant benefits over standard metal-on-polyethylene hip implants for older patients.
Bhandari et al (2005) reported a meta-analysis of 6 randomized controlled studies suggested that bisphosphonates have a beneficial effect with regard to maintaining more peri-prosthetic bone mineral density than that in controls. However, the limitations of the available studies and the lack of analyses of clinically relevant outcomes (e.g., functional outcomes, revision rates, and quality of life) necessitate the planning and conduct of a sufficiently sized, methodologically sound trial with clinically relevant end points. Until this has been done, the current evidence regarding the beneficial effects of bisphosphonates on peri-prosthetic bone following total joint (e.g., knee and hip) arthroplasty should be interpreted with caution.
A technology assessment of hip implants by the Institute for Clinical Effectiveness and Health Policy (Augustovsky et al, 2006) found that the clinical trials comparing ceramic against conventional prostheses found no significant differences in the revision rate among the different types of prostheses. In case series of patients with the ceramic prosthesis, reported revision rates at 10 years were less than 10 %, which is considered within acceptable limits and comparable to those reported for conventional prostheses. Similar results have been reported for metal-on-metal hip prostheses, where randomized controlled trials with follow-up up to 5 years found no differences between metal-on-metal and conventional prostheses in effectiveness and complication rates (Augustovsky et al, 2006). The assessment noted that, although there are some reports of an increase in cancer in persons with metal-on-metal hip prostheses, there are other reports evaluating metal-on-metal prostheses with follow-up up to 28 years that have found no increase in the incidence of any cancer. The assessment stated that no study comparing ceramic prosthesis with metal-on metal prosthesis was found. The assessment concluded that, although interim results with both the ceramic and metal-on-metal prostheses are promising, available studies have found no significant differences in revision rates during follow-up periods of 10 to 15 years. The assessment stated that, because the advantages of these materials may be observed at longer terms, their potential benefits would be greatest for younger patients (under 50 years of age) (Augustovsky et al, 2006).
In a meta-analysis, Smith and colleagues (2010) compared the clinical and radiological outcomes and complication rates of hip resurfacing (HRS) and total hip arthroplasty (THA). A systematic review was undertaken of all published (Medline, CINAHL, AMED, EMBASE) and unpublished or gray literature research databases up to January 2010. Clinical and radiological outcomes as well as complications of HRS were compared to those of THA using risk ratio, mean difference, and standardized mean difference statistics. Studies were critically appraised using the CASP appraisal tool. A total of 46 studies were identified from 1,124 citations. These included 3,799 HRSs and 3,282 THAs. On meta-analysis, functional outcomes for subjects following HRS were better than or the same as for subjects with a THA, but there were statistically significantly greater incidences of heterotopic ossification, aseptic loosening, and revision surgery with HRS compared to THA. The evidence base showed a number of methodological inadequacies such as the limited use of power calculations and poor or absent blinding of both patients and assessors, possibly giving rise to assessor bias. The authors concluded that on the basis of the current evidence base, HRS may have better functional outcomes than THA, but the increased risks of heterotopic ossification, aseptic loosening, and revision surgery following HRS indicate that THA is superior in terms of implant survival.
Garbuz and associates (2010) conducted a prospective randomized clinical trial to compare clinical outcomes of resurfacing versus large-head metal-on-metal THA. These researchers randomized 107 patients deemed eligible for resurfacing arthroplasty to have either resurfacing or standard THA. Patients were assessed for quality-of-life outcomes using the PAT-5D index, WOMAC, SF-36, and UCLA activity score. The minimum follow-up was 0.8 years (mean of 1.1 years; range of 0.8 to 2.2 years). Of the 73 patients followed at least 1 year, both groups reported improvement in quality of life on all outcome measures. There was no difference in quality of life between the 2 arms in the study. Serum levels of cobalt and chromium were measured in a subset of 30 patients. In both groups cobalt and chromium was elevated compared to baseline. Patients receiving a large-head metal-on-metal total hip had elevated ion levels compared to the resurfacing arm of the study. At 1 year, the median serum cobalt increased 46-fold from baseline in patients in the large-head total hip group, while the median serum chromium increased 10-fold. At 1 year, serum cobalt was 10-fold higher and serum chromium 2.6-fold higher than in the resurfacing arm. Due to these excessively high metal ion levels, the authors recommended against further use of this particular large-head THA.
Selection Criteria for Metal-on-Metal or Ceramic-on-Ceramic Total Hip Implants:
Member with diseases/conditions of the hip that cause chronic pain and functional impairment; e.g.,
Avascular necrosis: age less than or equal to 70, severe pain and functional impairment; or
Fracture: displaced fracture and bone quality deficient; or
Osteoarthritis: age less than or equal to 70, moderate/severe pain and severe functional impairment; or
Revision: age less than or equal to 70, moderate pain and functional impairment;
Conservative measures such as weight loss, anti-inflammatory medication, reasonable restriction of activity, and use of a cane have failed; and
Member is not allergic to components of the implant (e.g., cobalt, chromium or alumina).
Contraindications for Total Hip Implants:
Active infection of the hip joint or any other regions; or
An absence or relative insufficiency of the abductor musculature; or
Any process that is rapidly destroying bone; or neurotrophic arthritis; or
Any unstable medical conditions that would significantly increase the risk of morbidity or mortality (e.g., cardiac, pulmonary, liver, genitourinary, or metabolic disease; hypertension; and abnormal serum electrolyte levels); or
Rapidly progressive neurological diseases.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
ICD-9 codes covered if selection criteria are met:
Osteoarthrosis, localized, primary, pelvic region and thigh
Osteoarthrosis, localized, secondary, pelvic region and thigh
Osteoarthrosis, localized, not specified whether primary or secondary, pelvic region and thigh
Pathologic fracture of neck of femur (hip)
Aseptic necrosis of bone, site unspecified
Aseptic necrosis of bone, head and neck of femur
820.00 - 820.9
Fracture of neck of femur
Late effects of fracture of neck of femur
996.40 - 996.48
Mechanical complication of internal orthopedic device, implant, and graft
Joint replaced by other means, hip
The above policy is based on the following references:
Streicher RM. Metal-on-metal articulation in total hip arthroplasty: The case for using metal-on-metal. J Arthroplasty. 1998;13(3):343-345.
Walker PS, Blunn GW. Metal-on-metal articulation in total hip arthroplasty: The case for improving metal- or ceramic-on-polyethylene. J Arthroplasty. 1998;13(3):339-343.
Jazrawi LM, Kummer FJ, Di Cesare PE. Hard bearing surfaces in total hip arthroplasty. Am J Orthop. 1998;27(4):283-292.
Faulkner A, Kennedy LG, Baxter K, et al. Effectiveness of hip prostheses in primary total hip replacement: A critical review of evidence and an economic model. Health Technol Assess. 1998;2(6):1-133.
Randle R, Gordiev K. Metal-on-metal articulation in total hip arthroplasty: Preliminary results in 57 cases. Aust N Z J Surg. 1997;67(9):634-636.
Tountas AA. The historical development and clinical results on metal on metal total hip systems. Clin Orthop. 1997;340:283-284.
Visuri T, Pukkala E, Paavolainen P, et al. Cancer risk after metal on metal and polyethylene on metal total hip arthroplasty. Clin Orthop. 1996;329(Suppl):S280-S289.
Black J. Metal on metal bearings. A practical alternative to metal on polyethylene total joints? Clin Orthop. 1996;329(Suppl):S244-S255.
Hilton KR, Dorr LD, Wan Z, et al. Contemporary total hip replacement with metal on metal articulation. Clin Orthop. 1996;329(Suppl):S99-S105.
Dorr LD, Hilton KR, Wan Z, et al. Modern metal on metal articulation for total hip replacements. Clin Orthop. 1996;333:108-117.
Wagner H, Wagner M. Metal/metal articulating interfaces. Orthopedics. 1996;19(9):749-752.
Amstutz HC, Campbell P, McKellop H, et al. Metal on metal total hip replacement workshop consensus document. Clin Orthop. 1996;329(Suppl):S297-S303.
Schmalzried TP, Peters PC, Maurer BT, et al. Long-duration metal-on-metal total hip arthroplasties with low wear of the articulating surfaces. J Arthroplasty. 1996;11(3):322-331.
Amstutz HC, Grigoris P. Metal on metal bearings in hip arthroplasty. Clin Orthop. 1996;329(Suppl):S11-S34.
Muller ME. The benefits of metal-on-metal total hip replacements. Clin Orthop. 1995;311:54-59.
Fraser J. Knee and hip joint replacements. Longer lasting prostheses. Aust Fam Physicians. 1999;28(11):1109-1111, 1114-1115.
Sieber HP, Rieker CB, Kottig P. Analysis of 118 second-generation metal-on-metal retrieved hip implants. J Bone Joint Surg Br. 1999;81(1):46-50.
Zahiri CA, Schmalzried TP, Ebramzadeh E, et al. Lessons learned from loosening of the McKee-Farrar metal-on-metal total hip replacement. J Arthroplasty. 1999;14(3):326-332.
Dorr LD, Wan Z, Longjohn DB, et al. Total hip arthroplasty with use of the Metasul metal-on-metal articulation. Four to seven-year results. J Bone Joint Surg Am. 2000;82(6):789-798.
Harkess JW. Arthroplasty of hip. In: Campbell's Operative Orthopaedics. Vol I. 9th ed. ST Canale, ed. St. Louis, MO: Mosby; 1998; Ch. 7: 296-471.
Quintana JM, Azkarate J, Goenaga JI, et al. Evaluation of the appropriateness of the hip joint replacement techniques. Intl J Tech Assess Health Care. 2000;16(1):165-177.
Lombardi AV Jr, Mallory TH, Alexiades MM, et al. Short-term results of the M2a-taper metal-on-metal articulation. J Arthroplasty. 2001;16(8 Suppl 1):122-128.
Garino JP. Modern ceramic-on-ceramic total hip systems in the United States: Early results. Clin Orthop. 2000;(379):41-47.
Clarke IC, Good V, Williams P, et al. Ultra-low wear rates for rigid-on-rigid bearings in total hip replacements. Proc Inst Mech Eng [H]. 2000;214(4):331-347.
Bierbaum BE, Nairus J, Kuesis D, et al. Ceramic-on-ceramic bearings in total hip arthroplasty. Clin Orthop. 2002;(405):158-163.
Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Relative benefits of various types of hip prostheses. Pre-assessment No. 2. Ottawa, ON: CCOHTA; February 2002.
MacDonald SJ, McCalden RW, Chess DG, et al. Metal-on-metal versus polyethylene in hip arthroplasty: A randomized clinical trial. Clin Orthop. 2003;(406):282-296.
U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH. Ceramic TRANSCEND Hip Articulation System - P010001. New Device Approval. CDRH Consumer Information. Rockville, MD: FDA; March 25, 2003. Available at: http://www.fda.gov/cdrh/mda/docs/p010001.html. Accessed July 15, 2003.
Augustovski F, Pichon Riviere A, Alcaraz A, et al. Usefulness of ceramic prosthesis in total hip replacement. Report IRR No. 53. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2005.
Bhandari M, Bajammal S, Guyatt GH, et al. Effect of bisphosphonates on periprosthetic bone mineral density after total joint arthroplasty. A meta-analysis. J Bone Joint Surg Am. 2005;87(2):293-301.
Dumbleton JH, Manley MT. Metal-on-Metal total hip replacement: What does the literature say? J Arthroplasty. 2005;20(2):174-188.
Yoo JJ, Kim YM, Yoon KS, et al. Alumina-on-alumina total hip arthroplasty. A five-year minimum follow-up study. J Bone Joint Surg Am. 2005;87(3):530-535.
Dorr LD, Wan Z, Shahrdar C, et al Clinical performance of a Durasul highly cross-linked polyethylene acetabular liner for total hip arthroplasty at five years. J Bone Joint Surg Am. 2005;87(8):1816-1821.
Parker MJ, Gurusamy K. Arthroplasties (with and without bone cement) for proximal femoral fractures in adults. Cochrane Database Syst Rev. 2006;(3):CD001706.
Parker MJ, Gurusamy K. Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2006;(4):CD001708.
Augustovski F, Pichon Riviere A, Alcaraz A, et al. Usefulness of ceramic or metal on metal prostheses in total hip replacement [summary]. Report IRR No. 84. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2006.
Khan M, Kuiper JH, Richardson JB. Can cobalt levels estimate in-vivo wear of metal-on-metal bearings used in hip arthroplasty? Proc Inst Mech Eng [H]. 2007;221(8):929-942.
Morshed S, Bozic KJ, Ries MD, et al. Comparison of cemented and uncemented fixation in total hip replacement: A meta-analysis. Acta Orthop. 2007;78(3):315-326.
Nowicki P, Chaudhary H. Total hip replacement in renal transplant patients. J Bone Joint Surg Br. 2007;89(12):1561-1566.
Daras M, Macaulay W. Total hip arthroplasty in young patients with osteoarthritis. Am J Orthop (Belle Mead NJ). 2009;38(3):125-129.
Garcia-Rey E, Cruz-Pardos A, Garcia-Cimbrelo E. Alumina-on-alumina total hip arthroplasty in young patients: Diagnosis is more important than age. Clin Orthop Relat Res. 2009;467(9):2281-2289.
Hooper GJ, Rothwell AG, Stringer M, Frampton C. Revision following cemented and uncemented primary total hip replacement: A seven-year analysis from the New Zealand Joint Registry. J Bone Joint Surg Br. 2009;91(4):451-458.
Pospischill M, Kranzl A, Attwenger B, Knahr K. Minimally invasive compared with traditional transgluteal approach for total hip arthroplasty: A comparative gait analysis. J Bone Joint Surg Am. 2010;92(2):328-337.
Smith TO, Nichols R, Donell ST, Hing CB. The clinical and radiological outcomes of hip resurfacing versus total hip arthroplasty: A meta-analysis and systematic review. Acta Orthop. 2010;81(6):684-695.
Garbuz DS, Tanzer M, Greidanus NV, et al. The John Charnley Award: Metal-on-metal hip resurfacing versus large-diameter head metal-on-metal total hip arthroplasty: A randomized clinical trial. Clin Orthop Relat Res. 2010;468(2):318-325.
Walsh J. Metal-on-metal hip resurfacing as an alternative to total hip arthroplasty. Technology Assessment. San Francisco, CA: California Technology Assessment Forum (CTAF); October 19, 2011.
Azegami S, Gurusamy KS, Parker MJ. Cemented versus uncemented hemiarthroplasty for hip fractures: A systematic review of randomised controlled trials. Hip Int. 2011;21(5):509-517.
Qu X, Huang X, Dai K. Metal-on-metal or metal-on-polyethylene for total hip arthroplasty: A meta-analysis of prospective randomized studies. Arch Orthop Trauma Surg. 2011;131(11):1573-1583.
U.S. Food and Drug Administration (FDA). Concerns about metal-on-metal hip implant systems. Silver Spring, MD: FDA; updated March 29, 2012.
U.S. Food and Drug Administration (FDA). Information for orthopaedic surgeons on meta-on-metal hip implant surgery. Silver Spring, MD; FDA; updated March 29, 2012.
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.