Spine Bone Cements Outcomes - Post Market Follow-up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTeknimed
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit.
Disqualifiers
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
Trial population
Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Vertebroplasty (VP)
DeviceVertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Kyphoplasty (KP)
DeviceKyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Pedicular Screw Augmentation (PSA)
DevicePedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength
Treatment groups
500 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: F20 VP1 intervention
Group B: F20 KP1 intervention
Group C: SPINEFIX VP1 intervention
Group D: SPINEFIX KP1 intervention
Group E: SPINEFIX PSA1 intervention
Group F: HIGH V+ VP1 intervention
Group G: HIGH V+ KP1 intervention
Group H: OPACITY+ VP1 intervention
Group I: OPACITY+ KP1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 monthsSecondary outcomes
1
Restoration of quality of life
Evaluated through short questions : Oswestry Disability Index (ODI score)
Time frame
24 months2
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
Time frame
24 months3
Stabilization of vertebrae
Radiographic imaging
Time frame
24 months4
Adverse events
All adverse events occured during surgery and through study completion
Time frame
10 years Source ClinicalTrials.gov