NL-OMON49162RecruitingNot Applicable
Safety and clinical performance of the GEM-Power cable system in adult spinal deformity surgery: a first in human clinical investigation - The GEM-Power study
Medisch Universitair Ziekenhuis Maastricht0 sites14 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 < 40 kg/m2
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
- •Active malignancy
- •Active alcohol or drugs abuser, defined by currently undergoing treatment for
- •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
Investigators
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