Things to know
Being informed of the risks involved in any surgical procedure is essential. Below, you will find important information for patients considering SI Joint Fusion.
What is the TransLoc 3D™
SI Joint Fusion System?
The modular TransLoc 3D™ SI Joint Fusion System is a surgical procedure that incorporates state-of-the-art 3D printed titanium macro and microporosity in the lateral oblique compression screw and ultra-porous posterior titanium implant. The posterior titanium implant employs our patented and proven CornerLoc-ing technology1. The lateral oblique screw components of the TransLoc 3D™ System can be used on their own as a transfixing compression system or may be used together with the TransLoc 3D™ posterior implant or a CornerLoc™ GRAFT to create a truly 3-dimensional hybrid construct.
Our TransLoc 3D™ Screws pass through the ilium, across the SI joint, and into the sacrum using a Lateral Oblique approach. This approach avoids sensitive anatomy, including the Gluteal artery, Gluteal nerves, and muscles that are potential obstacles of the straight Lateral approach.
TransLoc 3D™ implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D™ Screw may be implanted alone. The TransLoc 3D™ Posterior Implant is intended only for use along with a TransLoc 3D™ Screw implanted in the same sacroiliac joint.
What was the TransLoc 3D™ SI Joint Fusion System designed to treat?
The TransLoc 3D™ SI Joint Fusion System was specifically designed to address the pain and instability associated with certain types of sacroiliac joint dysfunction. SI joint dysfunction can cause pain in the lower back, hip, buttocks, and down into the leg. The TransLoc 3D™ Screw is intended for sacroiliac joint 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
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
The TransLoc 3D™ Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D™ Posterior Implant is implanted, it must be used with a TransLoc 3D™ Screw implanted across the same sacroiliac joint.
What should I consider before choosing to undergo the TransLoc 3D™ SI Joint Fusion Procedure?
When it is suspected that some or all of your symptoms could be attributed to SI joint instability, it is recommended to begin with conservative treatment options. Conservative treatment may include physical therapy, chiropractic manipulation, patient-specific exercise programs, or bracing.
Pain management evaluation and intervention may be the next step, including pain medications or therapeutic injections, which may provide some people with temporary relief but often only work short-term. Radiofrequency ablation (RFA) has also been used with some success, but similar to injections, it may only provide temporary relief.
SI joint stabilization should only be considered after non-surgical interventions have failed to provide an enduring solution to your pain. Stabilizing the SI joint can provide enduring pain relief.
What are some risks associated with the TransLoc 3D™ procedure?
Potential risks specific to the TransLoc 3D™ SI Joint Fusion System include, but are not limited to:
- Post-operative infection, wound dehiscence, and/or wound necrosis
- Implant loosening, migration, or fracture/breakage
- Pain, discomfort, and/or abnormal sensations due to the presence of the device
- Stress shielding leading to loss of bone density
- Metal sensitivity or allergic (or other foreign body) reaction
Warnings and Precautions:
- Implants are for SINGLE USE ONLY and should never be re-used, reprocessed, or re-sterilized as this may compromise structural integrity and/or create risk of contamination leading to injury
- Healthcare professionals should be trained in the use of this system prior to use
- Woman of childbearing age should consult their physician to see if fusing the SI joint(s) would impact their ability to experience natural childbirth
- Factors such as the patient’s activity level, mental condition, or occupation should be considered with respect to patient selection and potential compliance
- The patient should be advised not to smoke or consume alcohol during the bone healing process
- A successful result may not be achieved in every surgical procedure
Please contact your doctor if you have any questions about the risks mentioned here.
Patient Guide Brochure
Find out more about the sacroiliac (SI) joint, SI joint dysfunction, and the comprehensive suite of options that CornerLoc™ provides. You can request a digital copy of our CornerLoc GRAFTS™ and TransLoc 3D™ patient guide brochures to be sent to you via email. You can also download a copy now.
