Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Launched by COMPLEJO ASISTENCIAL UNIVERSITARIO DE LEÓN URGENCIAS · Oct 29, 2020

Keywords

ClinConnect Summary

The clinical trial titled "Prospective i-FactorTM Analysis Fusion Rate and Quality of Life" is studying a new type of bone graft called i-Factor™ to see how well it helps patients with spinal deformities heal after surgery. This trial aims to determine how effective this graft is in promoting spinal fusion—where bones grow together—and how it impacts the quality of life for patients undergoing complex spinal surgeries. Currently, the standard method for obtaining bone for these procedures is limited and can cause complications, especially in patients with conditions like osteoporosis. The i-Factor™ graft may offer a better solution.

To participate in this trial, individuals must be adults diagnosed with a spinal deformity, such as scoliosis, and require surgery involving at least five levels of the spine. They should also be able to provide written consent and have certain medical imaging tests done before surgery. Participants can expect to be closely monitored after their surgery to assess both their recovery and overall well-being. Importantly, those with certain medical conditions or previous surgeries may not be eligible to join. This study could lead to improved treatment options and better management of healthcare resources in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of legal age.
• • Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs.
• • Patients who provide their informed consent in writing. (In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative).
• • Present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery.
• • The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.
• Exclusion Criteria:
• • Patients who are expected to be unavailable for follow-up.
• • Patients with mental disabilities that make it difficult for them to fill in the questionnaires.
• • Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.
• • Patients who are going to have cemented and / or expansive screws, Peek boxes or another type of material other than Titanium.
• • Underlying neurological or neuromuscular disease.
• • Underlying inflammatory or tumor disease.