NCT05828784
Not yet recruiting
Not Applicable
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
SPS srl1 site in 1 country35 target enrollmentStarted: December 1, 2023Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- SPS srl
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Bone fusion rate
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who have provided hospital consent for surgical treatment;
- •Male patients and non-pregnant female patients between the ages of 18 and 75 years;
- •Patients requiring single-level interbody fusion in the L3-L4 and L4-L5 tract;
- •Patients with degenerative diseases of the spine, such as lumbar canal stenosis, lumbar discopathy, degenerative spondylolisthesis grade I;
- •Patients with a BMI \<= 30;
- •Patients physically and mentally willing and able to comply with postoperative indications;
- •Patient able to understand the Italian language;
- •If the investigator decides to fuse an additional level for spinal stability during surgery, this is not an exclusion criterion; however, only one level will be measured to comply with the surgical indication.
- •Female patients who are pregnant or planning to become pregnant during the course of the study;
- •Obese patients with a BMI index \> 30.
Exclusion Criteria
- •Patients with:
- •systemic or localized infection;
- •Inflammatory or autoimmune disease;
- •hypercalcemia;
- •coagulation disorders;
- •metabolic disorders;
- •insulin-dependent diabetes;
- •alterations or complications of thyroid function;
- •overt allergy to calcium phosphate salts;
- •self-reported allergies to drugs and/or medical devices;
Outcomes
Primary Outcomes
Bone fusion rate
Time Frame: 9 months
the evaluation of the success rate in achieving bone fusion defined as bone regeneration/fusion capacity, understood as lack of loosening and presence of continuous trabecular bone bridge in the absence of radiolucency lines, verified by diagnostic imaging (CT) and evaluated according to the Brantingan scale;
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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