SPACE (SPS ADVANCED CAGE): SPS Spacer for Intervertebral Fusion, Longitudinal, Prospective Clinical Study (SPACE)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Treatment of Degenerative Diseases of the Spine
• Intervention / Treatment: Device: Intersomatic arthrodesis

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
    • Contact: Andrea Barbanera, MD; Phone Number: +390131206489; Email: segreteria@andreabarbanera.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 35 consecutive patients

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone fusion rate	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;	9 months

Collaborators and Investigators

• Sponsor: SPS srl

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): March 2, 2026
• Study Completion (Anticipated): May 4, 2026

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SPS101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No