Summary Of Evidence

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Analysis of Evidence

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Abstract:
Joint replacement surgery, also known as arthroplasty, has proved to be an important medical advancement. Arthroplasty surgery is most commonly performed for diseases which affect the function of the hip joint and knee joint, but is also performed on ankles, shoulders, and phalanges. In addition, the arthroplasty may be total (involving the entire joint) or partial (involving less than the entire joint).

Note: This local coverage determination (LCD) only addresses total hip and knee replacement surgery. The indications outlined in this LCD are not to be applied for unicompartmental knee replacement surgery. Failed previous unicompartmental joint replacement is an indication for performing a total knee arthroplasty.

Total Knee Arthroplasty (TKA)

The knee joint includes the lower end of the femur, the upper end of the tibia and the patella. The knee joint has three compartments, the medial, the lateral and the patellofemoral. The surfaces of these compartments are normally covered with articular cartilage and are bathed in synovial fluid. The most common reason for knee arthroplasty is arthritis of the knee joint. Arthritis may cause pain, stiffness, or other symptoms which limit normal activities such as walking, squatting, and climbing stairs. Additional indications for knee arthroplasty include osteonecrosis, malignancy, and other degenerative conditions. The goal of knee arthroplasty is to relieve pain and improve or increase patient function.

Total Hip Arthroplasty (THA) (TKA)

The hip joint is made up of two components: a ball (femoral head) and socket (acetabulum). These components are covered with articular cartilage and are bathed in synovial fluid produced by a synovial membrane. Hip arthroplasty is most often performed due to symptoms arising from arthritis, osteonecrosis, malignancy, and degenerative conditions. The goal of hip arthroplasty is to relieve pain and improve or increase patient function.

Revision Arthroplasty

Revision arthroplasty is performed on an individual who has had a prior hip or knee arthroplasty. Revision arthroplasty may be needed when pain or other symptoms occur as a result of failure of the prior surgery. Failure may occur as a result of infection of the joint, bone loss in the structures supporting the prosthesis, fracture, aseptic loosening of the components, wear of the prosthetic components, and for other reasons.

Indications:

Total Knee Arthroplasty (TKA)

TKA is considered reasonable and necessary for individuals with one or more of the following*:

1. Advanced Joint disease and all of the following (a,b,c):
   
   1. The joint disease is evidenced by conventional radiography, or magnetic resonance imaging (MRI)*; and
   2. Pain or functional disability attributable to the advanced joint disease; and
   3. Unsuccessful non-surgical medical management*, when appropriate, and attempted for a minimum of 3 months. (When non-surgical medical management is not appropriate, the medical record must clearly document the basis for that conclusion);
      or
2. Failure of a previous osteotomy; or
3. Distal femur fracture; or
4. Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues; or
5. Failure of previous unicompartmental knee replacement; or
6. Avascular necrosis of the knee; or
7. Proximal tibia fracture

*See Documentation Requirements in the attached Billing and Coding Article for additional information.


Replacement/Revision Knee Arthroplasty

Replacement/Revision knee arthroplasty is considered reasonable and necessary for individuals with one or more of the following*:

• Loosening of one or more component; or
• Fracture or mechanical failure of one or more components, or
• Infection, or
• Periprosthetic fracture of distal femur, proximal tibia or patella, or
• Progressive or substantial periprosthetic bone loss, or
• Bearing surface wear with symptomatic synovitis, or
• Implant or knee misalignment, or
• Knee stiffness/arthrofibrosis, or
• Tibiofemoral instability, or
• Extensor mechanism instability

*See Documentation Requirements in the attached Billing and Coding Article for additional information.

Total Hip Arthroplasty (THA)

THA is considered reasonable and necessary for individuals with one or more of the following*:

1. Advanced Joint disease and all of the following (a,b,c):
   
   1. The joint disease is evidenced by conventional radiography, or magnetic resonance imaging (MRI) *; and
   2. Pain or functional disability attributable to the advanced joint disease; and
      c
   3. Unsuccessful non-surgical medical management*, when appropriate and attempted for a minimum of 3 months. (When non-surgical medical management is not appropriate, the medical record must clearly document the basis for that conclusion);
      or
2. Malignancy of the joint involving the bones or soft tissues of the pelvis or proximal femur; or
3. Avascular necrosis (osteonecrosis of femoral head); or
4. Fracture of the femoral neck; or
5. Acetabular fracture; or
6. Non-union or failure of previous hip fracture surgery; or
7. Mal-union of acetabular or proximal femur fracture

*See Documentation Requirements in the attached Billing and Coding Article for additional information.

Replacement/Revision Hip Arthroplasty

Replacement/Revision knee arthroplasty is considered reasonable and necessary for individuals with one or more of the following*:

• Loosening of one or both components; or
• Fracture or mechanical failure of the implant; or
• Recurrent or irreducible dislocation; or
• Infection; or
• Treatment of a displaced periprosthetic fracture; or
• Clinically significant leg length inequality not amenable to conservative management; or
• Progressive or substantial bone loss; or
• Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction; or
• Clinically significant audible noise; or
• Adverse local tissue reaction.

*See Documentation Requirements in the attached Billing and Coding Article for additional information.

Bilateral Surgery

When bilateral TKA or bilateral THA is performed, the criteria listed above and documentation requirements below apply to the each joint upon which surgery is performed.

Limitations

TKA or THA is not considered reasonable or necessary when none of the criteria above are met.

TKA or THA is not considered reasonable or necessary when one or more of the following contraindications are present:

• Active infection of the hip or knee joint or active systemic bacteremia; and/or
• Active skin infection (exception recurrent cutaneous staph infections) or open wound within the planned surgical site of the hip or knee; and/or
• Rapidly progressive neurological disease except in the clinical situation of a concomitant displaced femoral neck fracture