Mr. Newton Ede

Mr. Newton Ede

iFuse Sacroiliac Joint Stabilisation (SIJ)

Mr. Newton Ede has performed many sacroiliac joint stabilization procedures in the last 2 years. He is the leading user of iFuse in the West Midlands. As a recognized expert in this specialist technique, Mr. Newton Ede accepts national and international referrals to both his NHS and Private Practice. Mr. Newton Ede has trained in the latest minimally invasive surgical (MIS) techniques, including the use of the iFuse Implant System from SI-BONE, Inc., a medical device company pioneering MIS sacroiliac (SI) joint treatment. iFuse is currently the only implant specifically recommended by the National Institute of Clinical Excellence

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Mr. Newton Ede

iFuse Sacroiliac Joint Stabilisation (SIJ)

News

Mr Newton Ede and iFuse featured on BBC West Midlands Today.

Background information about Sacroiliac Pain and Sacroiliac Stabilisation

The sacroiliac (SI) joint is a significant cause of low back pain. Clinical publications have identified the SI joint as a pain generator in 15-30% of chronic low back pain patients.1-4 In addition, the SI joint is a pain generator in up to 43% of patients with continued or new-onset low back pain after a lumbar fusion.5 The iFuse Implant System manufactured by SI-BONE Inc. is a minimally invasive surgical SI joint treatment option that provides stabilization
and fusion of the SI joint for some causes of SI joint pain. This is accomplished by inserting triangular-shaped titanium implants across the joint to maximize post-surgical stability and weight bearing capacity. The procedure is done through a small incision and usually takes less than two hours. Multiple published studies on iFuse have documented procedure safety and effectiveness.6 There are potential risks associated with the iFuse Implant
System. It may not be appropriate for all patients and all patients may not benefit

Sacroiliac Joint (SI Joint) Anatomy

The sacroiliac joint (SI joint) is located in the pelvis; it links the iliac bones

(pelvis) to the sacrum (lowest part of the spine above the tailbone). It is

an essential component for shock absorption to prevent impact forces

from reaching the spine.

Do you have SI Joint Problems?

The SI joint is a significant cause of low back pain. Clinical publications have identified the SI joint as a pain generator in 15-30% of chronic low back pain patients.1-4 In addition, the SI joint is a pain generator in up to 43% of patients with continued or new onset low back pain after a lumbar fusion. Like any other joint in the body, the SI joint can be injured and/or become degenerative. When this happens, people can feel pain in their buttock and sometimes in the low back and legs.

This is especially true while lifting, running, walking or even sleeping on the involved side. According to scientific data, it’s common for pain from the SI joint to feel like disc or low back pain. For this reason, SI joint disorders should always be considered in low back pain diagnosis. Do you experience one or more of the symptoms listed below?

Low back pain
Sensation of low extremity: pain, numbness, tingling, weakness
Pelvis/buttock pain
Hip/groin pain
Feeling of leg instability (buckling, giving way)
Disturbed sleep patterns
Disturbed sitting patterns (unable to sit for long periods, sitting on one side)
Pain going from sitting to standing.

Making a Diagnosis

A variety of tests performed during the physical examination may help reveal the SI joint as the cause of your symptoms. Sometimes, X-rays, CT-scan or MRI may be helpful in the diagnosis of SI joint-related problems. The most relied upon method to accurately determine whether the SI joint is the cause of your low back pain symptoms is to inject the SI joint with a local anesthetic. The injection will be delivered under either X-ray or CT guidance to verify accurate placement of the needle in the SI joint. If your symptoms are decreased by at least 50%, it can be concluded that the SI joint is either the source of or a major contributor to your low back pain. If the level of pain does not change after SI joint injection, it is less likely that the SI joint is the cause of your low back pain.

Treatment Options

Once the SI joint is confirmed as the cause of your symptoms, treatment can begin. Some patients respond to physical therapy, use of oral medications, or injection therapy. These treatments are often performed repetitively, and frequently symptom improvement using these therapies is temporary. At this point, you and your surgeon may consider other options, including minimally invasive surgery.

SI Joint Fusion with the iFuse Implant System

The iFuse Implant System is designed to provide stabilization and fusion for certain SI joint disorders. This is accomplished by inserting triangular shaped titanium implants across the sacroiliac joint to maximize postsurgical stability and weight bearing capacity. The procedure is done through a small incision and usually takes less than two hours. Multiple published studies on iFuse have documented procedure safety and effectiveness.

SI Joint Fusion with the iFuse Implant System

The Indications Risks of Sacroiliac Joint Stabilisation (iFuse)

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
If any of the following apply to you, you may not be a candidate for iFuse.

• Deformities or anatomic variations that prevent or interfere with implant placement.
• Tumour of sacral or ilial bone.
• Active infection at treatment site.
• Unstable fracture of sacrum and or ilium involving the sacroiliac joint.
• Allergy to metal components.

Women of childbearing potential should be cautioned that vaginal delivery of a fetus may not be advisable following SI joint fusion. If pregnancy occurs, the woman should review delivery options with her obstetrician.
As with other surgical procedures used to treat SI joint conditions, the risks associated with the iFuse surgical procedure include, but are not limited to the following:
• Adverse reactions to anesthesia
• Hemorrhage (internal bleeding)
• Muscle damage
• Hematoma (blood pooled under the skin) or seroma (clear fluid under the skin) at the implant site
• Neurological deficit, nerve root or peripheral nerve injury, irritation or damage (damage to nerves, permanent or temporary)
• Vascular injury (damage to a blood vessel) or damage resulting in catastrophic or fatal bleeding
• Neurovascular (blood vessel and nerve) injury
• Damage to lymphatic vessels and or lymphatic fluid exudation (leakage)
• Injury to intra-pelvic structures
• Infection of the wound, deep infection, peritonitis (infection in the abdomen)
• Wound dehiscence (the surgery incision opens up)
• Pulmonary or systemic embolism (clot in lungs or blood vessel system)
• Thrombosis, thrombophlebitis (blood clot and swelling of blood vessels)
• Death
• Bruising
• Local swelling
• Radiation exposure
Potential risks specifically associated with the iFuse Implants and instrumentation include, but are not limited to the following:
• Infection
• Pain, discomfort, or abnormal sensations due to presence of the implant
• Instrument failure resulting in a complication
• Migration (moving), loosening or fracture of the implant
• Pain in muscle(s) due to altered biomechanics (the positioning of your hip, leg, and foot during normal daily activities)
• Nerve root or peripheral nerve root irritation due to local swelling or altered biomechanics (changes in position of your hip, leg, and foot during normal daily activities)
• Loss of fixation/stabilization (implant becomes loose from the bones)
• Metal sensitivity, or allergic reaction
• Failure of a device to improve symptoms and/or function
• Increased pain at treated or adjacent levels (lumbar spine above and hips below)
• Need for re-operation or removal of the implant(s)
• Implant rejection
• Response to wear debris (small metal particles that come loose from the device causing a tissue response)
• Decrease in bone density due to stress shielding (loss of bone mass due to the implant assuming some of the normal daily load of the SI joint)
• Failure to achieve SI joint fusion
• A potential difficulty in delivering fetus vaginally due to a device-related restriction of SI joint stretching

NICE Guidance

The National Institute for Clinical Excellence (which guides UK Doctors, surgeons, and hospitals) issued guidance of support for sacroiliac fusion through minimally invasive procedures. They made the following recommendations:
• “Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent, and audit.”
• “This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain.”
• The case for adopting the iFuse implant system to treat chronic sacroiliac joint pain is supported by the evidence. Using iFuse leads to improved pain relief, better quality of life and less disability compared with non-surgical management.
Mr. Newton Ede is delighted that NICE have made this supportive recommendation. He would assure his patients that he adheres to all the audit and governance procedures at both hospital sites. He is highly experienced in minimally invasive techniques for spinal surgery. He introduced and pioneered Minimally invasive procedures at the Royal Orthopaedic Hospital having completed fellowship training at the Robert Jones Agnes Hunt Hospital

Hospital surgery

All surgery takes place either at the internationally renowned Royal Orthopaedic Hospital Birmingham or the BMI Priory hospital Both hospitals are situated in South Birmingham within easy reach of national and international transport links.