Health Problem: Damage to major joints, such as the knee, hip, or spine, may be caused by diseases and conditions such as osteoarthritis, rheumatoid arthritis, fracture, bone tumors, and osteonecrosis. Symptoms associated with these conditions include persistent pain and limited function. Joint replacement surgery (arthroplasty) and associated procedures are intended to relieve pain and increase the mobility and function of the damaged joint and bone. The use of standard “off-the-shelf” implants is the established protocol for arthroplasty procedures, which are commonly performed. More than 1 million of these procedures are performed in the United States every year, with the annual rate expected to increase to almost 4 million by 2030. The advent of commercially available 3-dimensional (3D) printing manufacturing technology, with the production of patient-specific implants, offers an alternative to standard implants and a possibility of improving surgical outcomes and increasing implant durability.

Technology Description: 3D printing, also known as additive manufacturing or rapid prototyping, is a manufacturing technique used to build a product from the ground up, layer by layer. In the medical industry, 3D printing has been utilized for a variety of applications, including the production of orthopedic implants. Titanium is commonly used to print orthopedic implants.

Controversy: While evidence regarding the efficacy and safety of 3D-printed implants for use in orthopedic applications is emerging, this technology has not been in clinical use for a sufficient duration to draw conclusions. Long-term follow-up is typically needed to evaluate the health outcomes of patients who have undergone arthroplasty and other reconstructive orthopedic procedures. It is unclear whether 3D-printed devices offer any advantages over the long term compared with standard manufactured implants. The metal materials used in 3D orthopedic implants may cause allergic reactions, potentially leading to significant morbidity, including aseptic loosening, pseudotumor formation, osseointegration failure, and ultimately, device failure. Although uncommon, it is unclear how to accurately determine which patients will experience these adverse events.

Key Questions:

  • Do 3D-printed implants improve clinical and radiographic outcomes following orthopedic surgery?

  • Do 3D-printed implants improve the quality of life in patients undergoing orthopedic surgery?

  • How does the efficacy of 3D-printed implants compare with standard implants in terms of clinical outcomes?

  • Are 3D-printed implants safe and how does their risk of revision compare with standard implants?

  • Have definitive patient selection criteria been established for 3D-printed implants?

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