Study on Long-term Safety of NVDX3 Implant for Patients with Distal Radius Fracture or Low-grade Degenerative Lumbar Spondylolisthesis

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment called NVDX3, which is an implant used in certain bone-related conditions. The diseases being studied in this trial include Distal Radius fracture, a type of wrist fracture, and Low grade degenerative lumbar spondylolisthesis, a condition affecting the spine where one of the vertebrae slips out of place. The treatment, NVDX3, is an osteogenic implant, meaning it is designed to support bone growth and repair, and it is made from human allogenic origin, which refers to cells or tissues obtained from a donor of the same species.

The purpose of this study is to document the long-term safety of the NVDX3 implant. Participants in the study will have previously been involved in core clinical trials with NVDX3 and will continue to be monitored for safety over a period of 10 additional years. This involves yearly follow-up visits to ensure the implant remains safe for use over a long period. The study will collect information on any serious adverse events (SAEs) or other side effects related to the implant from the time of screening until 10 years after the initial study.

Participants in this study will have agreed to these follow-up visits and will have signed an informed consent form to confirm their understanding and willingness to participate in this long-term safety study. The study aims to provide valuable information on the safety of the NVDX3 implant for patients with the specified conditions, contributing to the understanding of its long-term effects and potential benefits.

1 implantation of NVDX3

The process begins with the implantation of the NVDX3, an osteogenic implant of human allogenic origin. This step is necessary for patients with conditions such as a distal radius fracture or low-grade degenerative lumbar spondylolisthesis by interbody spine fusion.

2 initial follow-up

After the implantation, an initial follow-up is conducted to ensure the implant is functioning as expected and to monitor any immediate reactions or complications.

3 yearly follow-up visits

Patients are required to attend a yearly follow-up safety visit for a duration of 10 years. These visits are crucial for documenting the long-term safety of the NVDX3 implant.

During these visits, any adverse events (AEs) or serious adverse events (SAEs) related to the implant will be recorded and assessed.

4 completion of follow-up

The follow-up period concludes 120 months after the initial core study. At this point, a comprehensive evaluation of the implant’s long-term safety is completed.

Who Can Join the Study?

The patient must have a Distal Radius fracture or a Low grade degenerative lumbar spondylolisthesis. A Distal Radius fracture is a break near the wrist, and Low grade degenerative lumbar spondylolisthesis is a condition where one of the lower back bones slips over the one below it.
The patient must be implanted with the NVDX3 device.
The patient must have previously participated in one of the NVDX3 core clinical trials.
The patient must agree to attend a yearly follow-up safety visit for 10 additional years.
The patient must understand and agree to participate in the long-term follow-up study by signing the informed consent. This means they have been informed about the study and agree to take part in it.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients with a Distal Radius fracture cannot participate. This is a type of broken bone in the wrist area.
Patients with Low grade degenerative lumbar spondylolisthesis by interbody spine fusion are excluded. This condition involves a slight slipping of one of the bones in the lower back, which may have been treated with a type of spine surgery.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier de Luxembourg	Luxembourg	Luxembourg

Trial status

Country	Status	Recruitment Start
Luxembourg	Recruiting	05.08.2024

Trial locations

Investigated drugs:

Nvdx3

NVDX3 is an osteogenic implant made from human allogenic material. It is designed to support bone growth and repair. The main goal of the trial is to ensure that this implant is safe for long-term use in patients.

Investigated diseases:

Radius fracture

Distal Radius Fracture – A distal radius fracture is a break near the wrist end of the radius, one of the two large bones in the forearm. It often occurs when a person falls onto an outstretched hand. The fracture can cause pain, swelling, and difficulty moving the wrist or hand. Over time, the bone may heal, but the process can involve changes in the alignment of the wrist. This can lead to stiffness or reduced range of motion if not properly managed. The healing process varies depending on the severity of the fracture and the individual’s overall health.

Low Grade Degenerative Lumbar Spondylolisthesis – Low grade degenerative lumbar spondylolisthesis is a condition where one of the lower vertebrae slips forward over the one below it. This slippage is often due to age-related changes in the spine, such as arthritis. It can lead to back pain, stiffness, and sometimes nerve compression, causing leg pain or weakness. The progression is typically slow, with symptoms worsening over time. The condition may affect daily activities and mobility. It is more common in older adults and can be influenced by factors like posture and physical activity.

Trial ID:

2024-511661-11-01

Protocol code:

NVDX3-CLN0X

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on Long-term Safety of NVDX3 Implant for Patients with Distal Radius Fracture or Low-grade Degenerative Lumbar Spondylolisthesis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?