NCT05828784: SPACE

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

Not yet recruiting NA Last updated 25 April 2023

What this trial tests

NA trial testing Intersomatic arthrodesis in Treatment of Degenerative Diseases of the Spine in 35 participants. Not yet recruiting.

Timeline

1 December 2023

Primary endpoint
2 March 2026

4 May 2026

Quick facts

Lead sponsor	SPS srl
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 December 2023
Primary completion	2 March 2026
Estimated completion	4 May 2026
Sites	1 location across Italy

Drugs / interventions tested

• Intersomatic arthrodesis

Conditions studied

• Treatment of Degenerative Diseases of the Spine — all drugs for Treatment of Degenerative Diseases of the Spine →

Sponsor

SPS srl

Who can join

Adults 18 to 75, any sex, with Treatment of Degenerative Diseases of the Spine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.