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

NCT ID: NCT05828784

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-05-04

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.

Conditions

Treatment of Degenerative Diseases of the Spine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

35 consecutive patients

Group Type: OTHER

Intersomatic arthrodesis

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SPS srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Countries

Italy

Facility Contacts

Andrea Barbanera, MD

Role: primary

segreteria@andreabarbanera.it

+390131206489

Other Identifiers

SPS101

Identifier Type: -

Identifier Source: org_study_id