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

Launched by SPS SRL · Apr 12, 2023

Keywords

ClinConnect Summary

The SPACE clinical trial is studying a new treatment for people with degenerative diseases of the spine, which can cause pain and difficulty moving. Researchers want to see how well a special intervertebral spacer, used in spinal surgery, works when combined with a bioceramic bone substitute. They will look at how effectively this treatment helps bones heal and fuse together, as well as its safety by tracking any side effects or complications. Additionally, the trial aims to measure improvements in pain and disability levels in participants after 9 to 14 months compared to their condition before surgery.

To participate in the trial, patients must be between 18 and 75 years old and have specific spine issues that require surgery, such as lumbar canal stenosis or degenerative spondylolisthesis. They should also have a body mass index (BMI) of 30 or less and be able to understand Italian. However, people with certain health conditions, like infections or autoimmune diseases, or those who smoke heavily or abuse drugs, will not be eligible to join. Participants can expect to undergo surgery and will be monitored closely for their recovery and any changes in their health over the following months. This trial is not yet recruiting, so there is still time for interested individuals to learn more before deciding if they want to take part.

Gender

ALL

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).