Clincosm LogoSign in Get a demo

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

Sponsor
SPS srl (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05828784
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
29.1
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intersomatic arthrodesis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Mar 2, 2026
Anticipated Study Completion Date :
May 4, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Bone fusion rate [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;

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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;

  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo Alessandria Italy 15121

Sponsors and Collaborators

  • SPS srl

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SPS srl
ClinicalTrials.gov Identifier:
NCT05828784
Other Study ID Numbers:
  • SPS101
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 25, 2023