Evaluation of NVDX3 Osteogenic Implant for Interbody Spine Fusion in Low Grade Degenerative Lumbar Spondylolisthesis in Adults

The primary objective of this study is to evaluate the efficacy of **NVDX3**, an osteogenic implant of human allogenic origin, in the treatment of low grade degenerative lumbar spondylolisthesis through interbody spine fusion in adults. This condition involves the forward displacement of a vertebra, which can lead to pain and functional impairment. The use of NVDX3 aims to promote bone growth and stability, potentially improving patient outcomes by enhancing spinal fusion and reducing symptoms associated with this degenerative condition.

The clinical trial involves participants diagnosed with **low grade degenerative lumbar spondylolisthesis** undergoing interbody spine fusion. The study population includes both male and female subjects, with an age range of 18 to 65 years. Participants are generally in good health, excluding the specified medical condition. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed by the sponsor.

The clinical trial is designed to evaluate the efficacy and safety of **NVDX3**, an osteogenic implant of human allogenic origin, in the treatment of low grade degenerative lumbar spondylolisthesis by interbody spine fusion in adults. The study follows a randomized, double-blind, controlled trial design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on January 2, 2023, and is projected to conclude by April 30, 2025, encompassing a total duration of approximately 28 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomly assigned to either the treatment or control group. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' progress, assess the implant's integration, and evaluate any adverse events. The end-of-study visit will mark the completion of the trial, where final assessments will be conducted to gather comprehensive data on the primary and secondary endpoints.

The expected length of participant involvement in the study is approximately 24 months, contingent upon individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include non-compliance with study procedures, withdrawal of consent, or the occurrence of significant adverse events that compromise participant safety. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the integrity of the research and the welfare of the participants.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial will assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on January 2, 2023, with an estimated completion date of April 30, 2025. The efficacy assessment will be conducted in accordance with the trial's phase 7 protocol. Specific parameters or endpoints for evaluating efficacy have not been detailed in the available data. The trial will adhere to standard clinical trial methodologies to ensure the accurate measurement and analysis of efficacy outcomes. The process will involve systematic data collection and analysis, although specific tools or instruments for efficacy assessments are not specified in the provided information.