back abnormalities spinal deformities
Conditions
Interventions
Use of the GEM-power cable system during adult spinal deformity surgery.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or non-pregnant females • > 50 years of age • Adult spinal deformity determined as an abnormality of spinal alignment in the axial, coronal or sagittal plane amenable for surgical treatment • Planned surgical spinal fusion of > 4 levels (> 5 vertebrae) with the use of surgical rods and screws • BMI
Exclusion criteria
Exclusion criteria: • Patients with metal allergy / intolerance Female patients that are pregnant or plan to become pregnant • Patients judged by the surgeon mentally incapable to follow study requirements • Previous spinal procedures or compromised anatomy which limit sublaminar wire fixation • Active malignancy • Active alcohol or drugs abuser, defined by currently undergoing treatment for his abuse • Known systemic or metabolic disorders leading to progressive bone deterioration except patients with osteoporosis with a T-score of minimal -3,5 (below -3,5 is exclusion) • Use of systemic corticosteroids within the last 3 months ( inhaled steroids are no reason for exclusion) • presence of an active or suspected infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint of the study is assessment of the safety of the GEM-Power Cable System in adult spinal deformity patients. This is evaluated by the frequency, timing, and gravity of adverse events linked to the procedure and / or use of the biomaterial | — |
Secondary
| Measure | Time frame |
|---|---|
| -evaluation of the performance of the use of the GEM-power cable system by measuring the maintenance of surgical spinal correction -Evaluation of pain and quality of life by way of several questionaires | — |
Countries
Netherlands
Outcome results
None listed