Safety and clinical performance of the GEM-Power cable system in adult spinal deformity surgery: a first in human clinical investigatio

Recruiting

Conditions: back abnormalities
spinal deformities
10023213
10005944

Registration Number: NL-OMON49162

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 14

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
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint of the study is assessment of the safety of the<br /><br>GEM-Power Cable System in adult spinal deformity patients. This is evaluated by<br /><br>the frequency, timing, and gravity of adverse events linked to the procedure<br /><br>and / or use of the biomaterial</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-evaluation of the performance of the use of the GEM-power cable system by<br /><br>measuring the maintenance of surgical spinal correction<br /><br>-Evaluation of pain and quality of life by way of several questionaires</p><br>