spinal fusion Spondylodesis
Conditions
Interventions
According to a randomization scheme, one side of the spine will be grafted with
the synthetic ceramic material AttraX® Putty instead of bone harvest from the
iliac crest which is currently the gold
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * To be treated with instrumented posterolateral thoracolumbar spinal fusion, with or without additional posteriorly inserted interbody devices (PLIF, TLIF), because of (1) deformity, (2) structural instability and/or (3) expected or potential instability, for example as a result of decompression for spinal stenosis or benign lesions; 1. Deformity is defined as a scoliosis in the coronal plane of >20° and/or a sagittal balance disturbance according the SRS classification on standardized standing full spine radiographs; 2. Preoperative instability is defined as >2mm translation in standing radiographs; 3. Decompression for spinal stenosis is done in the occurrence of radiological evidence of stenosis on MRI and clinical leg and/or back pain with one or more of the following phenomena: radiculopathy, sensory deficit, motor weakness, reflex pathology or neurogenic claudication.;* Non-responsive to at least 6 months of non-operative treatment prior to study enrollment; * Fusion indicated for one or more levels in the T10 to S1/ilium region; * Willing and able to understand and sign the study specific Patient Informed Consent; * Skeletally mature between 18 and 80 years of age;
Exclusion criteria
Exclusion criteria: * Any previous surgical attempt(s) for spinal fusion (revision surgery); * Previous treatments that compromise fusion surgery like irradiation; * Previous autologous bone grafting procedures that compromise the quality and amount of iliac crest bone grafting; * Indication for spinal fusion because of a traumatic reason, like a spinal fracture or traumatic instability; * Active spinal and/or systemic infection; * Spinal metastasis in the area intended for fusion; * Systemic disease or condition, which would affect the subjects ability to participate in the study requirements or the ability to evaluate the efficacy of the graft (e.g. active malignancy, neuropathy); * At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate); * Participation in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment in the study; * Female patients who intend to be pregnant within 1.5 year of enrollment in the study; * Body mass index (BMI) larger than 35 (morbidly obese); * Being expected to require additional surgery to the same spinal region within the next 6 months; * Current or recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of this study are the posterior spinal fusion rate after one year (based on CT-scans), and the complication rate and potential relation of (serious) adverse events with AttraX® Putty. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the resorption characteristics during the first year, volume of bridging bone mass after one year, evaluation of iliac crest pain, correlation of the posterior fusion rate to the presence of interbody fusion after one year and the posterior spinal fusion rate after two years. | — |
Countries
Netherlands
Outcome results
None listed