This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.
18 years of age or older.
Skeletally mature.
Male or female.
Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.
Participation in another interventional clinical investigation
Suspected or confirmed pregnancy
Morbid obesity
Neurological or psychiatric conditions preventing compliance with postoperative care and instructions
Patients aged 18 years or older who underwent cervical or thoracolumbar spinal instrumentation and/or fusion surgery under current medical practice with appropriate indications, in whom at least one of the investigational devices was used, and who meet all inclusion and no exclusion criteria. The study will enroll a total of 561 subjects across 17 product groups (33 subjects per group, accounting for a 10% dropout rate) at 3 centers in Turkey. All patients who underwent reverse shoulder arthroplasty or hemiarthroplasty using Tıpmed™ Primary Hip Prosthesis Systems, who were informed about this study and voluntarily agreed to participate will be included.
Cohort
Prospective
Titania® Cervical Interbody Fusion Cage (Titanium)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Interbody Fusion Cage (PEEK)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Cervical Stabilization System
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Plate System
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Dynamic Stabilization System (Elastic Rod)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Disc Prosthesis (Titanium)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Disc Prosthesis (PEEK)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Lumbar Interbody Fusion Cages (Titanium)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Lumbar Interbody Fusion Cages (PEEK)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Interspinous Fusion Device (Titanium)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Thoracolumbar Stabilization Systems
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Thoracolumbar Clamp Systems
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Bonegraft® Synthetic Bone Grafts
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Bonegraft® Bone Cement
DeviceThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
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Treatment groupsSee each treatment group below.
Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems)
The NDI is used to evaluate neck-pain-related disability. It consists of 10 items, each scored from 0 to 5. While the total raw score ranges from 0 to 50, results are expressed as a percentage (0-100%) for clinical evaluation, consistent with the referenced literature (Heller et al., 2009). Following clinical benchmarks, a reduction of ≥15% in the NDI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
The ODI is used to assess the impact of thoracolumbar pain on daily life activities (personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel). It consists of 10 items, each scored from 0 to 5. The total score is calculated using the formula: (total score x 100) / (5 x number of questions answered), resulting in a scale from 0 (best) to 100 (worst). Evaluations will be performed at baseline (pre-op) and at each follow-up visit (Day 12, Week 6, and Months 3, 6, and 12). A reduction of ≥15 points in the ODI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
Fusion rate for Spinal Fusion Systems
Fusion status will be evaluated using radiographs and/or CT scans (if available) at each postoperative follow-up visit. The assessment is based on the presence of a continuous trabecular bone bridge between the vertebral bodies. Fusion will be categorized into three groups: Solid Fusion: Presence of a continuous bone bridge between the vertebrae. Fibrous Fusion: Absence of a continuous bone bridge, but no signs of instability (translation \< 3 mm on dynamic radiographs). Non-fusion: Absence of a continuous bone bridge along with abnormal motion (\> 3 mm translation on radiographs). The evaluation will be concluded once solid fusion is achieved.
Adjacent segment motion in subjects with dynamic instrumentation
In subjects undergoing dynamic posterior stabilization, motion at the adjacent segments will be evaluated using flexion and extension radiographs (if available) at all follow-up visits. The primary assessment involves measuring the differences in the disc space angles. These measurements will be compared with baseline (preoperative) values to monitor changes in adjacent segment mobility over the 12-month follow-up period.
Clinical outcome assessment using Odom's Criteria
Patient clinical outcomes will be evaluated at each follow-up visit using Odom's Criteria, which classifies results as 'Excellent', 'Good', 'Fair', or 'Poor' based on symptom relief and the ability to perform daily activities. Clinical success is defined as the proportion of subjects achieving 'Excellent' or 'Good' scores, representing significant improvement compared to baseline.
Assessment of pain using Visual Analog Scale (VAS)
Pain intensity and changes in pain levels will be evaluated at each follow-up visit using the Visual Analog Scale (VAS) and compared with baseline measurements. Patients mark their pain level on a 100 mm (or 10 cm) line, where 0 represents no pain and 100 represents the worst pain. A decrease of ≥20 mm (or 2 cm) in pain intensity at the 12th-month follow-up compared to baseline is considered a successful clinical outcome.
Assessment of health-related quality of life with SF-12
Health-related quality of life and changes in quality of life perception will be evaluated at each follow-up visit using the SF-12 Health Survey and compared with baseline measurements. Each domain of the survey is evaluated independently. Scores for each domain range from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
Patient satisfaction assessment
Patient satisfaction will be evaluated at the final follow-up visit (12 months) using a 3-point Likert scale based on three specific questions directed to the subject. The scale consists of three response options: 'Yes', 'Undecided', and 'No'. The proportion of patients responding 'Yes' to the satisfaction questions will be analyzed to determine the overall treatment satisfaction rate.
Click on the lead sponsor to view all of their trials.
Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Lead sponsor
Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
Collaborator
