2.1 The iFuse implant system (SI‑Bone) is a titanium implant intended for use in people with chronic sacroiliac joint pain. iFuse is placed across the sacroiliac joint using minimally invasive surgery, where it is intended to stabilise the joint and to correct any misalignment or weakness that can cause chronic pain. The implant is triangular, which is designed to limit movement and spread shear stresses evenly. It has a porous metal coating, which the company claims promotes bone-on-bone growth and encourages joint fusion. Typically, 3 implants are used per joint, depending on the size of the pelvis. Implanting iFuse is a technically challenging procedure for which surgeons need specific training (provided at no additional cost by the company).
2.2 The cost of iFuse stated in the company's submission is £4,059, which includes 3 implants and the necessary consumables for the procedure. The cost of theatre time is estimated to be £1,310 per procedure (using HRG code HN13A‑F – Major hip procedures from NHS reference costs for 2015/16).
2.3 The claimed benefits in the case for adoption presented by the company are listed in the scope of this evaluation.
2.4 Chronic sacroiliac joint pain can affect people of any age and usually needs lifelong management. The standard of care is escalating non-surgical management, typically beginning with analgesic therapy (such as non-steroidal anti-inflammatory drugs or opioids) combined with physiotherapy. If these initial treatments are ineffective, invasive procedures may be considered. These include steroid injections into the sacroiliac joint itself and radiofrequency ablation to the nerves that supply the joint. Sacroiliac joint fusion may be considered if the chronic pain continues. This can be done through open surgery or through a minimally invasive procedure, using a device such as iFuse. Invasive procedures and surgical treatments for chronic sacroiliac joint pain are usually done by spinal surgeons and orthopaedic trauma pelvic surgeons working in specialist centres.
2.5 NICE has published interventional procedures guidance on minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain, which may be done using iFuse. The guidance recommends that the evidence supporting the procedure is adequate for it to be carried out with standard arrangements for clinical governance, consent and audit. The guidance also recommends that the procedure should only be done in people with a confirmed diagnosis of unilateral or bilateral sacroiliac joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption; and should only be carried out by surgeons who regularly use image-guided surgery for implant placement and have had specific training and expertise in minimally invasive sacroiliac joint fusion surgery for chronic pain.
2.6 The NICE guideline on low back pain and sciatica in over 16s refers to surgical interventions for treating low back pain and sciatica including spinal decompression, fusion and disc replacement. The guideline does not mention surgical interventions for treating sacroiliac joint pain.