Synthetic Cartilage Implants for Joint Pain

POLICY NUMBER

A.7.01.160

DESCRIPTION

Articular cartilage damage, either from a focal lesion or diffuse osteoarthritis, can result in disabling pain. Cartilage is a hydrogel, comprised mostly of water with collagen and glycosaminoglycans that does not typically heal on its own. There is a need for improved treatment options. In 2016, a synthetic polyvinyl alcohol hydrogel disc received marketing approval by the U.S. Food and Drug Administration for the treatment of degenerative or posttraumatic arthritis in the first metatarsophalangeal (MTP) joint. If proven successful for treatment of the MTP joint, off-label use is likely.

Articular Cartilage Damage

Articular cartilage damage may present as focal lesions or as more diffuse osteoarthritis. Cartilage is a biological hydrogel that is comprised mostly of water with collagen and glycosaminoglycans and does not typically heal on its own. Osteoarthritis or focal articular cartilage lesions can be associated with substantial pain, loss of function, and disability. Osteoarthritis is most frequently observed in the knees, hips, interphalangeal joints, first carpometacarpal joints, first metatarsophalangeal (MTP) joint, and apophyseal (facet) joints of the lower cervical and lower lumbar spine. Osteoarthritis less commonly affects the elbow, wrist, shoulder, and ankle. Knee osteoarthritis is the most common cause of lower-limb disability in adults over age 50. Osteoarthritis of the MTP joint with loss of motion (hallux rigidus) can also be severely disabling due to pain in the “toe-off” position of gait. An epidemiologic study found that osteoarthritis of the first MTP joint may be present in as many as 1 in 40 people over the age of 50.

Treatment

Treatment may include débridement, abrasion techniques, osteochondral autografting, and autologous chondrocyte implantation. Débridement involves the removal of the synovial membrane, osteophytes, loose articular debris, and diseased cartilage and is capable of producing symptomatic relief. Subchondral abrasion techniques attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect. Diffuse osteoarthritis of the knee, hip, shoulder, or ankle may be treated with joint replacement.

Early-stage osteoarthritis of the first MTP joint is typically treated with conservative management, including pain medication and change in footwear. Failure of conservative management in patients with advanced osteoarthritis of the MTP joint may be treated surgically. Cheliectomy (removal of bone osteophytes) and interpositional spacers with autograft or allograft have been used as temporary measures to relieve pain.

Although partial or total joint replacement have been explored for MTP osteoarthritis, complications from bone loss, loosening, wear debris, implant fragmentation, and transfer metatarsalgia are not uncommon. Also, since the conversion of a failed joint replacement to arthrodesis has greater complications and worse functional results than a primary arthrodesis (joint fusion), MTP arthrodesis is considered the most reliable and primary surgical option. Arthrodesis can lead to a pain-free foot, but the loss of mobility in the MTP joint alters gait, may restrict participation in running and other sports, and limits footwear options, leading to patient dissatisfaction. Transfer of stress and arthritis in an adjacent joint may also develop over time.

Because of the limitations of MTP arthrodesis, alternative treatments that preserve joint motion are being explored. Synthetic cartilage implants have been investigated as a means to reduce pain and improve function in patients with hallux rigidus. Some materials such as silastic were found to fragment with use. Other causes of poor performance are the same as those observed with metal and ceramic joint replacement materials and include dislocation, particle wear, osteolysis, and loosening.

Synthetic polyvinyl alcohol (PVA) hydrogels have water content, and biomechanical properties similar to cartilage and they are biocompatible. Polyvinyl alcohol hydrogels have been used in a variety of medical products including soft contact lens, artificial tears, hydrophilic nerve guides, and tissue adhesion barriers. This material is being evaluated for cartilage replacement due to the rubber elastic properties and, depending on the manufacturing process, high tensile strength and compressibility.

The Cartiva implant is an 8- to 10-mm PVA disc that is implanted with a slight protrusion to act as a spacer for the first MTP joint. It comes with dedicated reusable instrumentation, which includes a drill bit, introducer, and placer.

The Cartiva PVA implant was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of arthritis of the MTP joint. It has been distributed commercially since 2002 with approval in Europe, Canada, and Brazil. The Cartiva Synthetic Cartilage Implant (Wright Medical, Alpharetta, GA; now Stryker) was approved by the FDA through the premarket approval process (P150017) for painful degenerative or posttraumatic arthritis in the first MTP joint along with hallux valgus or hallux limitus and hallux rigidus. Lesions greater than 10 mm in size and insufficient quality or quantity of bone are contraindications. FDA product code: PNW.

POLICY

Synthetic cartilage implants are considered investigational for the treatment of articular cartilage damage.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/01/2019: New policy added. Approved by Medical Policy Advisory Committee.

08/14/2019: Policy description updated. Policy statement unchanged.

08/19/2020: Policy description updated. Policy statement unchanged.

08/30/2021: Policy description updated regarding the Cartiva implant. Policy statement unchanged.

08/10/2022: Policy reviewed; no changes.

10/13/2023: Policy description updated regarding the Cartiva PVA implant. Policy statement unchanged.

08/14/2024: Policy reviewed; no changes.

09/11/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.160

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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