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Studies

Interventional Recruiting

NCT06265038 on ClinicalTrials.gov

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

Official title: A Prospective, Single Center, Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion

  • Sponsor: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.
  • Enrollment: 99 (Estimated)
  • Study start: 2024-02-01 (Actual)
  • Primary completion: 2026-02-01 (Estimated)
  • Study completion: 2026-10-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders.
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.

The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:

* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
* To evaluate if implantation causes significant increase quality of life of the patients.
* To evaluate if using the device can be considered as safe overall.

Conditions

  • Degenerative Instability
  • Spondylolisthesis
  • Post-discectomy Syndrome
  • Post-traumatic Instability

Intervention / Treatment

  • Device: ReSpace TiCell Cage

Primary Outcome Measures

  • CT imaging_1 - cumulative fusion rate (At visit 4 (Month 24))
    For the determination of the cumulative fusion rate, radiographic evaluation (CT imaging with fine-cut axial and multiplanar reconstruction views) will be conducted by 2 independent examiners.
  • CT imaging_2 - fusion status (At visit 4 (Month 24))
    Standing flexion-extension angle will be measured with dynamic plain radiography to evaluate mobility to determine the fusion status.

Countries

Hungary

Locations and Investigators

Study Officials