This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Synthetic bone graft
Universitätsklinikum Bonn
Bonn, Germany
University of Cologne
Cologne, Germany
Ludwig-Maximilians-Universität München
München, Germany
Fusion rate
Assessed by x-ray and CT scan
Time frame: 12 months after surgery
Fusion rate
fusion rate at 6 and 24 months by x-ray/CT scan
Time frame: 6 and 24 months after surgery
Clinical Outcome Measure - pain
Assessed by VAS scores
Time frame: 6, 12 and 24 months
Clinical Outcome measure - Quality of Life
Oswestry Disability Index
Time frame: 6,12,and 24 months
Clinical Outcome measure - Quality of Life
SF-36 v2 short form, health questionnaire
Time frame: 6,12,and 24 months
Adverse events
Assessment of Adverse events
Time frame: 0-24 months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Buda Health Center
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Beaumont Hospital
Dublin, Dublin, Ireland
Fundacio Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinical de Barcelona & Clinical Corachan
Barcelona, Spain
HGU Gregorio Marañón
Madrid, Spain
University Hospital of Wales
Cardiff, United Kingdom
...and 5 more locations