Clinical trial NCT05828784: SPACE (SPS ADVANCED CAGE): SPS Spacer for Intervertebral Fusion, Longitudinal, Prospective Clinical Study
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Treatment of Degenerative Diseases of the Spine
Lead sponsor: SPS srl
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;
* tumor and/or infectious diseases of the spine;
* active neoplasms;

In addition, patients who:

* Abuse alcohol and drugs;
* Are affected by smoking (\> 20 cigarettes/day);
* Are on drug therapy that causes alteration of bone regeneration (e.g., chemotherapy);
* already had surgery (revision surgery).

Primary outcomes:
measure: Bone fusion rate
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Study officials:
References: