Clinical trial NCT06367582: Spine Bone Cements Outcomes - Post Market Follow-up
Official title: Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vertebral Fracture
Compression Fracture
Osteoporotic Fractures
Lead sponsor: Teknimed
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alleviation of Pain
timeFrame: 24 months
Secondary outcomes:
measure: Restoration of quality of life
timeFrame: 24 months
measure: Patient satisfaction
timeFrame: 24 months
measure: Stabilization of vertebrae
timeFrame: 24 months
measure: Adverse events
timeFrame: 10 years
measure: Antalgic Consumption
timeFrame: 24 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU HautePierre
state: Bas-Rhin
city: Mainvilliers
country: France
facility: Pôle Rachis Hôpital Privé d'Eure et Loir
state: Eure Et Loir
city: Toulouse
country: France
facility: Hôpital Toulouse Purpan
state: Haute Garonne
city: Le Mans
country: France
facility: Pôle Sud Santé
state: Sarthe
city: Chambéry
country: France
facility: Centre Hospitalier Métropole Savoie
state: Savoie
city: Lisbonne
country: Portugal
facility: Hospitale Cruz Vermelha Portuguesa
city: Barcelona
country: Spain
facility: Clínica Teknon Instituto de neurociencias
city: Granada
country: Spain
facility: Hospital Neurotraumatologico
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Terrassa
country: Spain
facility: Fundacio Assistencial Mutua de Terrassa - Edifici Estació
city: Zafra
country: Spain
facility: Hospital de Zafra
city: Kiev
country: Ukraine
facility: Institute of Traumatology and Orthopaedics
Study officials:
References: