Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases
Titanium
+ Carbofix
Bone Diseases+1
+ Musculoskeletal Diseases
+ Spinal Diseases
Treatment Study
Summary
Study start date: April 29, 2022
Actual date on which the first participant was enrolled.This clinical trial aims to compare the outcomes of using a carbon fiber device versus traditional titanium devices in patients who need spinal fusion surgery due to degenerative spinal diseases. Degenerative spinal diseases involve the gradual deterioration of the spine, leading to pain and mobility issues. The study focuses on patients requiring fusion at one or two levels in the lower back region. Carbon fiber devices are of interest because they do not interfere with imaging techniques like MRI and X-rays and have previously been used effectively in cancer patients undergoing radiation therapy. This trial could reveal whether carbon fiber offers better or comparable results to titanium, which is the standard material currently used. Participants in the study will undergo spinal fusion surgery, where either a carbon fiber or titanium device will be implanted to stabilize the spine. The study will observe the clinical and radiographic outcomes, meaning it will look at both the physical recovery and the images of the spine post-surgery to assess how well the devices are working. By comparing these two materials, researchers hope to determine which provides better stabilization and visualization benefits without compromising the patient's recovery or effectiveness of the treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.118 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location