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SPACE (SPS ADVANCED CAGE): SPS Spacer for Intervertebral Fusion, Longitudinal, Prospective Clinical Study
Sponsor: SPS srl
Summary
Space clinical study aims to evaluate the performance, in terms of efficacy and safety of an intervertebral spacer associated with a bioceramic bone substitute in the context of intervertebral surgery for degenerative diseases. Specifically, it is intended to evaluate: * the capacity for bone regeneration/fusion, defined as absence of loosening and presence of continuous trabecular bone bridge in the absence of radiolucency lines, verified by imaging (CT) and evaluated according to the Brantingan scale; * the safety of the medical device, through the incidence of any adverse events, complications, unexpected reactions, accidents; * the improvement of clinical outcome in terms of pain and disability, at 9/14 months follow-up compared with preoperative scores, by clinical indices such as ODI and VAS.
Official title: Italian Title:STUDIO CLINICO LONGITUDINALE, PROSPETTICO, PRE-CE PER LA VALUTAZIONE DELLA EFFICACIA E DELLA SICUREZZA DI UN CAGE INTERVERTEBRALE IN TITANIO ASSOCIATO AD UN SOSTITUTO OSSEO SINTETICO DI NATURA BIOCERAMICA NELLA NORMALE PRASSI CLINICA IN PROCEDURE DI FUSIONE INTERVERTEBRALE English Title: LONGITUDINAL, PROSPECTIVE, PRE-CE CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A TITANIUM INTERVERTEBRAL CAGE ASSOCIATED WITH A BIOCERAMIC SYNTHETIC BONE SUBSTITUTE IN NORMAL CLINICAL PRACTICE IN INTERVERTEBRAL FUSION PROCEDURES
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2023-12-01
Completion Date
2026-05-04
Last Updated
2023-04-25
Healthy Volunteers
No
Interventions
Intersomatic arthrodesis
Arthrodesis is an operative modality also used in the treatment of multiple recurrences of herniated discs, stenosis (narrowing) of the spinal anal, degenerative and malformative spondylolisthesis. The procedure can be performed with different surgical techniques, but in all cases it aims to achieve the same goal: to re-establish, through the use of spacers, the correct distance between two vertebral somes, in cases of disc degeneration, that are no longer able to fulfill their function; that is, they no longer absorb mechanical stresses and/or compress the nerve structures of the spine causing almost always unbearable (disabling) pain.
Locations (1)
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy