SPINE BONE CEMENTS OUTCOMES

Status Recruiting

Clinical Trial Summary

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

Clinical Trial Description

It is admitted that: - Cementoplasty procedures such as vertebroplasty and kyphoplasty are recommended in the treatment of painful vertebral compression fractures, due to their efficiency and safety - These mini-invasive procedures, where bone cement is injected into a partially collapsed vertebral body, are used to reduce pain and to provide mechanical stability - In most patients, a rapid pain relief and an increase in mobility and quality of life are obtained - Serious complications from bone cements leaks and adjacent vertebral fractures can be observed but remain rather rare - The use of spinal cement in pedicle screw augmentation procedures can be relevant to increase the strength of the screw fixation in the bone, particularly in osteoporotic patients. TEKNIMED has developed several bone cements currently used in vertebroplasty and kyphoplasty procedures in the treatment of vertebral weakness. Among those, one cement is also used in pedicle screw augmentation procedures. With the increasing use of these procedures, there is a need of real-life safety and efficacy data on the bone cements. This retro-prospective study is performed to confirm the safety and performance of TEKNIMED spine bone cements in their current clinical use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06367582
Study type	Observational
Source	Teknimed
Contact	Solange VAN DE MOORTELE, PhD
Phone	+33534252679
Email	s.vandemoortele@teknimed.com
Status	Recruiting
Phase
Start date	September 4, 2019
Completion date	September 30, 2039

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.