The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on prosthetic intervertebral disc replacement in the lumbar spine.
Artificial intervertebral discs have been developed to act as a functional prosthetic replacement unit for intervertebral units in much the same way as prostheses have been developed for a variety of joints such as the hip or knee. The design of most prosthetic discs is similar, with two metallic endplates separated by a more pliable inner core designed to emulate the biomechanical properties of the nucleus pulposus. The implantation of the prosthetic discs involves a small incision below the umbilicus. The diseased disc is partially or fully excised (depending on the prosthesis used). The vertebral endplates and surrounding spinal ligaments are preserved and help maintain implant stability. Single discs can be replaced, or alternatively, several levels can be replaced during the same surgery.
The standard intervention for patients with these indications would be discectomy and spinal fusion.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.