Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04174534
Brief Summary:
This study is designed as a post-marketing observational, controlled, prospective, non-inferiority study where the efficacy and safety of the Degenerative Disc Disease treatment by arthrodesis using PEEK(PolyEtherEtherKetone)-Titanium polyaxial interspinous posterior fusion device ROMEO®2 PAD will be compared to the gold standard treatment by instrumented circumferential arthrodesis.
The primary study aim is to evaluate functional improvement at 1 and 2 years after surgery. The fusion at 1 year and 2 years post-surgery, the short and long- term clinical and neurological success and patient related health status satisfaction will also be evaluated.
Detailed Description:
Lumbar spine fusion is the gold standard technique for the treatment of low-back pain due to various spinal pathologies mostly related to degenerative conditions. Pedicle-screws constructs are widely used to achieve a strong fixation but may be associated with potential complications.
ROMEO® 2 PAD is composed of two polyaxial titanium teethed plates to adapt to anatomical variations, one step locking mechanism and a radiolucent polymer cylinder.
The ROMEO®2 PAD is a posterior non pedicle supplemental fixation device intended for use in combination with an inter-somatic device, to achieve fusion at single or multilevel in the lumbar spine (L1-S1 inclusive). A range of six heights (from 8 to 18mm) are designed to fit anatomical variations. It is intended for plate fixation to the spinous process for the purpose of achieving spinal fixation.
The main objective of the study is the evaluation of functional improvement as measured by changes in Oswestry Disability Index (ODI) at 12 and 24 months after surgery, respectively.
The secondary objectives are:
* Evaluation of fusion rate at 12 and 24 months after surgery, respectively, based on CT scans.
* Evaluation of mobility at the treated level at 12 and 24 months after surgery, respectively, based on ROM (Range of motion) assessed using dynamic lumbar flexion-extension radiography.
* Evaluation of functional capacities post-surgery, as measured by ODI. Comparison between preoperative status and controls at 6 weeks, 6 months after surgery, respectively.
* Evaluation of Health-related Quality of Life (HR-QOL) improvement and patient satisfaction, as measured by SF-36 (Short Form 36) scores, the physical (PCS) and mental (MCS) components; comparison between preoperative status and controls at 6 weeks, 6, at 12 and 24 months after surgery, respectively.
* Evaluation of low back and legs pain as measured by Visual Analogue Scale (VAS) (changes in VAS scores): comparison between preoperative status and controls at 6 weeks, 6, 12 and 24 months after surgery, respectively.
Study:
NCT04174534
Study Brief:
Protocol Section:
NCT04174534