Treatment of Degenerative Diseases of the SpineSPACENCT05828784
SPACE (SPS ADVANCED CAGE): SPS Spacer for Intervertebral Fusion, Longitudinal, Prospective Clinical Study
A study testing Intersomatic arthrodesis in people with Treatment of Degenerative Diseases of the Spine, run by SPS srl at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment of Degenerative Diseases of the Spine
- What is being tested?
- Intersomatic arthrodesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Patients with:
- systemic or localized infection;
- Inflammatory or autoimmune disease;
- hypercalcemia;
- coagulation disorders;
- metabolic disorders;
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- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Andrea Barbanera, MD, +390131206489, segreteria@andreabarbanera.it
About this 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
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.
- Being tested
- Intersomatic arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intersomatic arthrodesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 35 consecutive patients | Other | Not described Receives: Device: Intersomatic arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Dec 2023 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion4 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Degenerative Diseases of the SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPS srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828784
- Sponsor's protocol ID
- SPS101
- Acronym
- SPACE
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05828784
- Acronym / sponsor ID
- SPACE / SPS101
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- SPS srlIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 4 May 2026 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 35 consecutive patients | Other | Device: Intersomatic arthrodesis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (17 listed)
- systemic or localized infection;
- Inflammatory or autoimmune disease;
- hypercalcemia;
- coagulation disorders;
- metabolic disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intersomatic arthrodesisArthrodesis 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. | Device | 35 consecutive patients |
Primary outcome
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;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intersomatic arthrodesis in people with Treatment of Degenerative Diseases of the Spine, run by SPS srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone fusion rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.