SPINE BONE CEMENTS OUTCOMES

Vertebral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367582
• Other study ID #: CV01-TK-SPINE
• Status: Recruiting
• Start date: September 4, 2019
• Est. completion date: September 30, 2039

Study information

• Verified date: April 2024
• Source: Teknimed
• Contact: Solange VAN DE MOORTELE, PhD
• Phone: +33534252679
• Email: s.vandemoortele[@]teknimed.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2039
• Est. primary completion date: September 4, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be 18 years or older

• Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study

o For prospective inclusion:

• Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study

o For retrospective inclusion:

• Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit.

• Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).

Exclusion Criteria:

Patients presenting one of the following conditions will not be included (contraindications per IFU):

• Procedures other than those stated in the INDICATIONS section

• Coagulation disorders, or severe cardiopulmonary disease

• Unstable vertebral fractures

• Compromise of the vertebral body or of the pedicle walls

• Hypersensitivity or allergy to one of the constituents of the product

• Patient clearly improving on more conservative treatment

• Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture

• Paediatric patients and pregnant or breast-feeding women.

Related Conditions & MeSH terms

• Compression Fracture
• Fractures, Bone
• Fractures, Compression
• Osteoporotic Fractures
• Spinal Fractures
• Vertebral Fracture

Intervention

Device:
• Vertebroplasty (VP)
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
• Kyphoplasty (KP)
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Métropole Savoie	Chambéry	Savoie
France	Pôle Sud Santé	Le Mans	Sarthe
France	Pôle Rachis Hôpital Privé d'Eure et Loir	Mainvilliers	Eure Et Loir
France	CHU HautePierre	Strasbourg	Bas-Rhin
France	Hôpital Toulouse Purpan	Toulouse	Haute Garonne
Portugal	Hospitale Cruz Vermelha Portuguesa	Lisbonne
Spain	Clínica Teknon Instituto de neurociencias	Barcelona
Spain	Hospital Neurotraumatologico	Granada
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Fundacio Assistencial Mutua de Terrassa - Edifici Estació	Terrassa
Spain	Hospital de Zafra	Zafra
Ukraine	Institute of Traumatology and Orthopaedics	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Teknimed

Countries where clinical trial is conducted

France,  Portugal,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alleviation of Pain	Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits	24 months
Secondary	Restoration of quality of life	Evaluated through short questions : Oswestry Disability Index (ODI score)	24 months
Secondary	Patient satisfaction	Evaluated through short questions : A. Are you satisfied with your surgery? Yes/No/Without opinion B. Has your health improved? Yes/Stable/No C. Given the results, would you accept this intervention again? Yes/No/Without opinion	24 months
Secondary	Stabilization of vertebrae	Radiographic imaging	24 months
Secondary	Adverse events	All adverse events occured during surgery and through study completion	10 years
Secondary	Antalgic Consumption	Antalgic consumption and the drug type at the Baseline and at the Follow-up visits	24 months