Hip resurfacing can be categorized in two ways: as a partial (hemi) hip resurfacing or as a total hip resurfacing. In partial hip resurfacing a femoral shell is implanted over the femoral head.  In total hip resurfacing, a femoral shell is implanted over the femoral head, and in addition, an acetabular shell is placed on the hip bone for the femur to fit into.

Medically Necessary:

Partial hip resurfacing of the femoral head, using an FDA approved device, is considered medically necessary in patients with osteonecrosis of the femoral head with subchondral collapse.

The use of metal-on-metal prosthesis for total hip resurfacing arthroplasty (HRA) is considered medically necessary in fit, active individuals who:

1. Have normal proximal femoral bone geometry and bone quality, and 
2. Would otherwise receive a conventional primary total hip replacement (THR), and
3. Are likely to live longer than current conventional THR prostheses are expected to last.

Investigational/Not Medically Necessary:

Total hip resurfacing is considered investigational/not medically necessary for all other indications not listed above.

Partial hip resurfacing is considered investigational/not medically necessary for all other indications not listed above.

Hemi hip resurfacing of the femoral head is an established procedure for patients with osteonecrosis of the femoral head.  In one case series of 33 hips, 91% of the devices were still implanted for a minimum of five years, with good or excellent results in 61%.  Another case series of 37 prostheses followed for seven years reported that 9 failed, requiring revision, but that 24 of the remaining 28 implants continued to function well with excellent or good hip scores. Several implant designs have been FDA approved for this purpose.

At the present time only one metal-on-metal device, the Birmingham Hip™ has received Pre Market Approval (PMA) from the FDA for the indication of total hip resurfacing. Other devices, such as the Buechel-Pappas™ Integrated Total Hip Replacement, which have previously received FDA PMA approval for total hip replacement, have also been granted 510k clearance for use in total hip resurfacing procedures. 510k clearance differs from PMA approval in that 510k clearance does not require the submission and rigorous review of clinical trial data prior to the subject device to be cleared for use in the market. Devices applying for 510k clearance need only prove that the subject device be substantially equivalent to a legally marketed device that is not subject to PMA. A substantially equivalent device is marketed subject to the same regulatory controls as the device to which it is found to be substantially equivalent. Manufacturers of devices that already have PMA approval frequently seek 510k approvals for additional indications to expand the use of their devices.  The Buechel-Pappas device is one example of this practice, having receiving PMA approval for use in total hip replacement surgery and subsequent 510k clearance for use in total hip resurfacing.

In addition to the Birmingham Hip™, several other devices are currently under investigation or are in use in Europe and other countries (i.e., Conserve Plus®, Cormet 2000™) for use in total hip resurfacing procedures. 

Interest in newer total hip resurfacing devices using a metal on metal (MoM) design have increased in the light of high failure rates reported on the polyethylene on metal (PoM) prostheses (Head, 1982; Treuting 1997). Prior to the advent of MoM devices, standard hip resurfacing and replacement devices have used a metal femoral component and a polyethelene acetabular component.  Research into the reason for failure of hip prostheses has discovered that a frequent reason for device failure is related to polyethylene debris created by friction and wear between the polyethylene articulating surface against the surface of the metal femoral component.  This polyethylene debris collects in the joint space where it is solicits an immune response. The immune response is not effective against the polyethylene particles, so the body’s defenses attack the bone adjacent to the prostheses, leading to bone loss and loosening of the implant (Beaule, 2002). The problem of debris collection and subsequent immune response is potentially greater in hip resurfacing procedures because resurfacing procedures involve the use of a femoral component with a much greater surface area compared to that used in total hip replacement procedures. It is proposed that this increase in surface area increases the volume of polyethylene debris in resurfacing procedures using PoM devices, thus increasing the likelihood of immune response and device failure. The results of a recent case series study including 114 patients who underwent PoM hip resurfacing  procedures reported a device survival rate of 47% over a 10 year period.  The authors indicated that the survival of PoM hip resurfacing devices was deemed unacceptable (Duijsens, 2005). 

The current evidence addressing the safety and efficacy of total hip resurfacing with MoM devices includes three small to medium sized randomized controlled trials, a case-control study and a handful of case series studies. Vendittoli and colleagues (2006) report the results of a randomized controlled study comparing the 12 month outcomes of 102 patients receiving MoM total hip replacement with 103 patients receiving MoM total hip resurfacing procedures. In their article they report no significant difference between the two groups on the WOMAC or Merle d’Aubigné-Postel scales. They also report a significantly higher activity level and quicker return to heavy or moderate activities in patients undergoing the resurfacing when compared to those receiving replacement. Both techniques present similar complication rates of 15%. Another controlled trial by Pollard and colleagues (2006) describes 5 to 7 year outcomes between of two groups of 54 patients each who received MoM total hip resurfacing or total hip replacement.  The authors report hip function was not significantly different between groups as measure by the Oxford hip score.  However, scores form the University of California at Los Angeles activity scale and EuroQol life score both found significantly better outcomes in the hip resurfacing group. Revisions rates were slightly lower in the resurfacing group (6% vs. 8%).  De Smet (2005) describes the results of a large case series study of252 patients receiving MoM total hip resurfacing procedures followed for 3-5 years.  The mean age of the study population as 49.7 years of age and the reported complication rate as 4.3% (n=11) and included sciatic nerve palsy (n= 2)and heterotopic ossification Brooker grade 1 (n= 3).The report indicates that results on the Harris Hip and Merle d’Aubigné-Postel scales indicate early clinical success in this population of predominantly young, active patients.  The result of these studies is promising and indicate that MoM total hip resurfacing is an acceptable alternative to total hip replacement in younger patients where bone conservation is a consideration in preparation for later total hip replacement surgery.

Hip replacement surgery aims to re-establish functional joint movement and alleviate pain associated with hip damage due to degenerative joint disease or trauma. In arthroplasty options for reconstruction of the hip include total hip replacement (THR), hemiarthroplasty (bipolar or unipolar), and partial or total hip resurfacing of the femoral head. 

In the standard total hip replacement operation, the femoral head and neck are removed, the femoral canal (marrow space) is reamed-out.  The damaged hip joint is replaced with an artificial prosthesis composed of two or three different components: 1) the head, a metal ball (stainless steel or cobalt chrome) that replaces the original femoral head, 2) the femoral component (a metal stem placed into the femur) and 3) the acetabular component (a plastic cup made of high-density polyethylene) that is implanted into the acetabulum. The stem may be secured using bone cement or press-fit for the bone to grow-into it.  In partial hip resurfacing a femoral shell is implanted over the femoral head only as a proposed treatment option for avascular necrosis with collapse of the femoral head and preservation of the acetabulum.

In total hip resurfacing operations the surgeon removes only the diseased or damaged surfaces of the head of the femur and the hip socket (acetabulum).  The femoral head is fitted with a spherical shell and the hip socket is lined with a thin spherical cup.  Both spherical cups form a pair of metal bearings.  Total hip resurfacing has been investigated in a broader range of patients including those with osteoarthritis, rheumatoid arthritis, and advanced avascular necrosis.  It has been proposed as an alternative to total hip arthroplasty, particularly in young active patients who would potentially outlive a total hip prosthesis.  Therefore, total hip resurfacing could be viewed as a time-buying procedure to delay the need for a total hip arthroplasty.

Proposed advantages of total hip resurfacing compared to total hip arthroplasty include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a total hip replacement, if required.  In addition, the resurfaced head is more similar in size to the normal femoral head, thus increasing the stability and decreasing the risk of dislocation compared to total hip arthroplasty.

Total hip resurfacing has undergone various evolutions over the past several decades, with modifications in prosthetic design and composition and implantation techniques.  For example, similar to total hip arthroplasty, the acetabular components of total hip resurfacing have been composed of polyethylene, a type of plastic.  However, over the years, it has become apparent that device failure was frequently related to polyethylene debris created by wear of polyethylene articulating surfaces (Treuting, 1997; Naudie, 2004; Harris 2001; Kadoya, 1998).  The polyethylene debris is attacked by the body's immune system.  The immune response is not effective against the plastic particles so, instead, the macrophages attack the adjacent bone (Ingham, 2005). This leads to bone loss.  Since debris accumulates in the area adjacent to the implant, the bone loss leads to loosening of the implant stem (Konttinen, 2005) .  This is the one of the main reason for revision surgery (Grigoris, 2006).  This problem is further aggravated in surface replacements because the larger size of the femoral head compared to total hip prosthesis increases the volume of debris wear particles.  The development of newer metal-on-metal device designs promises to avoid such complications.

At the present time only one metal-on metal device, the Birmingham Hip™, has received Pre-Marketing Approval (PMA) from the FDA for the indication of total hip resurfacing. Other devices, such as the Buechel-Pappas Integrated Total Hip Replacement, which have previously received FDA PMA approval for total hip replacement, have also been granted 510k clearance for use in total hip resurfacing procedures.  Several other devices are currently under investigation or in use in Europe and other countries (i.e., Conserve Plus®, Cormet 2000™). 

Other surgical interventions used to alleviate the symptoms of degenerative joint disease of the hip include, but are not limited to, osteotomy, arthrodesis and arthroscopy of the hip joint.  Non-surgical interventions and medications can also be used to, control these symptoms and delay or prevent the need for surgery. Once non-operative modalities have failed, femoral head-preserving procedures including grafting techniques, core decompression with vascularized or non-vascularized bone grafting, and upper femoral osteotomies have all been used with varying success.

Arthrodesis: fusion of the femur to the pelvis; primarily indicated in children who have unilateral degenerative disease of the hip and are unresponsive to non-operative measures

Arthroscopy: a minimally invasive surgical procedure used to investigate and treat traumatic and non-traumatic disorders of the hip; performed by means of an arthroscope introduced into the joint in order to visualize anatomical structures

Osteotomy: the aim of osteotomy in dysplastic or osteonecrotic hips is to restore and realign the position of the joint by means of a fixation device; for hips affected by osteonecrosis, the major goal of surgery is to move the necrotic segment away from the weight bearing area and restore blood supply to the necrotic zone

The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

ICD-9 Diagnosis

Services are Investigational/Not Medically Necessary:

For partial hip resurfacing when criteria are not met, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

When services may also be Medically Necessary when criteria are met:

CPT

ICD-9 Diagnosis

Services are Investigational/Not Medically Necessary:
For total hip resurfacing when criteria are not met, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

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3. Beaulé PE, Amstutz HC, Le Duff M, Dorey F. Surface arthroplasty for osteonecrosis of the hip: hemiresurfacing versus metal-on-metal hybrid resurfacing. J Arthroplasty. 2004b; 19(8 suppl 3):54-58.
4. Beaule PE, Le Duff M, Campbell P, et al.  Metal-on-metal surface arthroplasty with a cemented femoral component: a 7-10 year follow-up study. J Arthroplasty. 2004a; 19(8 Suppl 3):17-22. 
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9. Grecula MJ.  Resurfacing arthroplasty in osteonecrosis of the hip. Orthop Clin North Am. 2005; 36(2):231-42.
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15. Huo M. What’s new in hip arthroplasty. J Bone Joint Surg Am. 2002; 84-A (10): 1894-1905.
16. Ingham E, Fisher J.  The role of macrophages in osteolysis of total joint replacement. Biomaterials. 2005;26(11): 1271-12. 
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18. Konttinen YT, Zhao D, Beklen A, et al.  The microenvironment around total hip replacement prostheses. Clin Orthop Relat Res. 2005; (430):28-38. 
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1. Hayes, Inc.  Medical Technology Directory. Total Hip Resurfacing Arthroplasty. Hayes, Inc. Lansdale, PA. July 13, 2006.
2. National Institute for Clinical Excellence. Technology Appraisal Guidance No. 44. Guidance on the use of metal on metal hip resurfacing arthroplasty. Issue Date: June 2002. Review Date: February 2005. Available at:  http://www.nice.org.uk/page.aspx?o=TA044guidance. Accessed on August 11, 2006.
3. Vale L, Wyness L, McCormack K, et al. A systematic review of the effectiveness and cost-effectiveness of metal-on-metal hip resurfacing arthroplasty for treatment of hip disease. National Health Service (NHS) Health Technology Assessment Programme. NICE Technology Assessment Report. 2002; 6(15):1-109. Available at:  http://www.hta.nhsweb.nhs.uk/ProjectData/3_project_record_published.asp?Pjtid=1243. Accessed on August 11, 2006.
   

Birmingham Hip™ Resurfacing (BHR) System
Buechel-Pappas™ Integrated Total Hip Replacement
Conserve® Plus
Cormet 2000™
Hemi Hip Resurfacing
Hip Resurfacing
Partial Hip Resurfacing
Surface Hip Arthroplasty
Total Hip Resurfacing

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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