NCT06367582

Spine Bone Cements Outcomes - Post Market Follow-up

Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Teknimed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vertebral Fracture
• Compression Fracture
• Osteoporotic Fractures

Interventions

Type	Name	Description
DEVICE	Vertebroplasty (VP)	Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
DEVICE	Kyphoplasty (KP)	Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
DEVICE	Pedicular Screw Augmentation (PSA)	Pedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength

Timeline

• Start date: 2019-09-04
• Primary completion: 2029-09-04
• Completion: 2039-09-30
• First posted: 2024-04-16
• Last updated: 2025-09-09

Locations

12 sites across 4 countries: France, Portugal, Spain, Ukraine