Study to Confirm Safety and Effectiveness of ReSpace TiCell Cage Implants in Transforaminal Lumbar Fusion Surgery for Adults 18 to 80 Years Old

What this Trial Is About

Researchers are evaluating the performance and safety of ReSpace TiCell Cage implants used in Transforaminal Lumbar Interbody Fusion TLIF surgery. This study aims to confirm if these implants provide better results than current standard treatments for patients with degenerative lumbar spine conditions causing pain and reduced mobility. It also looks at whether the implants reduce back, hip, and leg pain, improve quality of life, and maintain overall safety. The study involves a single group of adult participants undergoing TLIF surgery with the ReSpace TiCell Cage implant combined with posterior fixation using pedicle screws and rods. The implant is designed to stabilize and restore the spines height and curve, helping bone grow through the device. This single-center, open-label trial will follow participants for up to 24 months to assess outcomes. Participants will be monitored through regular visits at 3, 6, 12, and 24 months after surgery. Assessments include CT imaging to check spinal fusion, pain measurement using a visual analog scale, and disability evaluation with the Oswestry Disability Index. The study tracks safety and effectiveness throughout this period to understand how well the implant supports spine healing and improves patient well-being.

Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF