Summary Of Evidence

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Analysis of Evidence

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Joint replacement surgery has been performed on millions of people over the past several decades and has proved to be an important medical advancement in the field of orthopedic surgery. The hip and knee are the 2 most commonly replaced joints. The knee is the largest joint in the body and includes the lower end of the femur, the upper end of the tibia and the patella. The knee joint has 3 compartments, the medial, the lateral and the patellofemoral. The surfaces of these compartments are covered with articular cartilage and are bathed in synovial fluid. The bones of the knee joint work together, allowing the knee to function smoothly. The hip is a large weight bearing joint made up of 2 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.

The most common reason for total knee replacement (TKR) surgery is arthritis of the knee joint. Types of arthritis include:

• Osteoarthritis,
• Rheumatoid arthritis and
• Traumatic arthritis (arthritis which occurs as a result of injury).

Arthritis causes a severe limitation in the activities of daily living (ADLs), including difficulty with walking, squatting, and climbing stairs. Pain is typically most severe with activity and patients often have difficulty getting mobilized when seated for a long time. Other findings include chronic knee inflammation or swelling not relieved by rest, knee stiffness, lack of pain relief after taking non-steroidal anti-inflammatory (NSAIDs) medications and failure to achieve symptom improvement with other conservative therapies such as steroid injections and physical therapy.

Osteonecrosis and malignancy are additional reasons to proceed with TKR surgery. The use of TKR in patients with malignancy must be weighed against considerations of life expectancy and possible alternative procedures to relieve pain. The goal of TKR is to relieve pain and improve or increase patient function.

Total hip replacement (THR) surgery is most often performed due to severe pain caused by osteoarthritis of the hip joint. Rheumatoid arthritis, traumatic arthritis, malignancy involving the hip joint and osteonecrosis of the femoral head are also causes for hip replacement surgery. The use of THR in patients with malignancy must be weighed against considerations of life expectancy and possible alternative procedures to relieve pain. The pain from the damaged joint usually limits ADLs, such as walking, bathing and cooking. The pain can also cause disruption of sleep due to the inability to lie on the hip while in bed. Pain relief not achieved by taking NSAIDs and failure to achieve symptom improvement with other conservative therapies such as physical therapy, activity modification and (in some patients) assistive device use are reasons for proceeding with a THR. The goal of THR surgery is to relieve pain and improve or increase patient function.

Occasionally, there may be a need to perform a reoperation on a previous THR or TKR. This is often referred to as a revision total knee or revision total hip. Circumstances that lead to the need for a revision total hip or knee are continued disabling pain and/or continued decline in function which can be attributed to failure of the primary joint replacement. Failure can be due to infection involving the joint, substantial bone loss in the structures supporting the prosthesis, fracture, aseptic loosening of the components and wear of the prosthetic components.

Total Knee Arthroplasty (TKA)

Indications:

This A/B MAC will consider TKR surgery medically necessary when 1 or more of the following criteria are met:

Advanced joint disease demonstrated by:

• Radiographic supported evidence or when conventional radiography is not adequate, magnetic resonance imaging (MRI) supported evidence (subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis); 
  
  
• Pain or functional disability from injury due to trauma or arthritis of the joint; and
  
  
• If appropriate, a history of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.);  
  
  
• Failure of a previous osteotomy; 
  
  
• Distal femur fracture; 
  
  
• Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues; 
  
  
• Failure of previous unicompartmental knee replacement; 
  
  
• Avascular necrosis of the knee; or
  
  
• Proximal tibia fracture

Non-surgical medical management is usually, but not always, implemented prior to scheduling total joint surgery. Non-surgical treatment as clinically appropriate for the patient’s current episode of care typically includes 1 or more of the following:

• Anti-inflammatory medications, analgesics, 
  
  
• Flexibility and muscle strengthening exercises, 
  
  
• Supervised physical therapy (ADLs diminished despite completing a plan of care), 
  
  
• Assistive device use, 
  
  
• Weight reduction as appropriate, or
  
  
• Therapeutic injections into the knee as appropriate.

In some circumstances, for example, if the patient has bone on bone articulation, severe deformity, or pain and significant disabling interference with ADLs, the surgeon may determine that non-surgical medical management would be ineffective or counterproductive, and that the best treatment option, after explaining the risks, is surgical. If medical management is deemed inappropriate, the medical record should indicate the rationale for and circumstances under which this is the case.

Indications for Replacement/Revision of TKA:

• Loosening of 1 or more components, 
  
  
• Fracture or mechanical failure of 1 or more components, 
  
  
• Infection, 
  
  
• Treatment of periprosthetic fracture of distal femur, proximal tibia or patella, 
  
  
• Progressive or substantial periprosthetic bone loss, 
  
  
• Bearing surface wear leading to symptomatic synovitis, 
  
  
• Implant or knee misalignment, 
  
  
• Knee stiffness/arthrofibrosis, 
  
  
• Tibiofemoral instability, or
  
  
• Extensor mechanism instability

Total Hip Arthroplasty (THA)

Indications:

This A/B MAC will consider THR surgery medically necessary when 1 or more of the following criteria are met:

Advanced joint disease demonstrated by:

• Radiographic supported evidence or when conventional radiography is not adequate, MRI supported evidence (subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis); 
  
  
• Pain that cannot be adequately controlled despite optimal conservation treatment or functional disability from injury due to trauma or arthritis of the joint; and
  
  
• If appropriate, a history of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. (If conservative therapy is not appropriate, the medical record must clearly document the rationale for why such approach is not reasonable.); 
  
  
• Malignancy of the joint involving the bones or soft tissues of the pelvis or proximal femur; 
  
  
• Avascular necrosis (osteonecrosis of femoral head); 
  
  
• Fracture of the femoral neck; 
  
  
• Acetabular fracture; 
  
  
• Nonunion or failure of previous hip fracture surgery; or
  
  
• Malunion of acetabular or proximal femur fracture

Non-surgical medical management is usually, but not always, implemented prior to scheduling total joint surgery. Non-surgical treatment as clinically appropriate for the patient’s current episode of care typically includes 1 or more of the following:

• Anti-inflammatory medications or analgesics, 
  
  
• Flexibility and muscle strengthening exercises, 
  
  
• Supervised physical therapy (ADLs diminished despite completing a plan of care), 
  
  
• Assistive device use, 
  
  
• Weight reduction as appropriate, or
  
  
• Therapeutic injections into the hip as appropriate.

Indications for Replacement/Revision of THA:

• Loosening of 1 or both components; 
  
  
• Fracture or mechanical failure of the implant; 
  
  
• Recurrent or irreducible dislocation; 
  
  
• Infection; 
  
  
• Treatment of a displaced periprosthetic fracture; 
  
  
• Clinically significant leg length inequality not amenable to conservative management; 
  
  
• Progressive or substantial bone loss; 
  
  
• Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction; 
  
  
• Clinically significant audible noise; or
  
  
• Adverse local tissue reaction.

Limitations:

This A/B MAC will not consider a TKR or THR medically necessary when the following contraindications are present:

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

The following conditions are relative contraindications to TKR or THR and if such surgery is performed in the presence of these conditions, it is expected that the rationale for proceeding with the surgery under such circumstances is clearly documented in the medical record:

• Absence or relative insufficiency of abductor musculature
  
  
• Any process that is rapidly destroying bone
  
  
• Neurotrophic arthritis

This local coverage determination (LCD) is only addressing medical necessity criteria for performing THR and TKR surgery. With respect to knee replacement surgery, there is a form of knee joint replacement surgery called unicompartmental knee replacement. This is typically done for patients with osteoarthritis of the knee in which the damage is contained to 1 compartment of the knee. 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 TKA.