Safety and clinical performance of the GEM-power Cable system in adult spinal deformity surgery: A first in human clinical investigatio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

•Signed and dated written informed consent prior to admission to the clinical investigation in accordance with good clinical practice (GCP) and local legislation
•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 [1], amenable for surgical treatment
•Planned surgical instrumented spinal fusion of > 4 levels (> 5 vertebrae)
•Body Mass Index index (BMI) < 40 kg/m2

Exclusion Criteria

•Patients with metal allergy/intolerance
•Patients with compromised anatomical integrity of the laminar arch or a previous spinal surgery which may have compromised the integrity of the laminar arch (i.e. laminectomy) at proximal construct levels.
•Previous spinal deformity correction surgery
•Patients with any form of kidney dysfunctioning
•Female patients that are pregnant or plan to become pregnant
•Patients unwilling to cooperate with the study protocol and follow up schedule
•Patients judged by the surgeon mentally incapable to follow study requirements
•Patients with neuromuscular or neuro-sensory deficit which would limit the ability to assess the performance of the device
•Diagnosed with active malignancy
•Active alcohol or drugs abuser as defined by currently undergoing treatment for this abuse or as judged by the surgeon is likely to interfere with protocol compliance
•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
•Chronic disease that compromises the immune system (e.g. known HIV or known hepatitis).
•Uncontrolled diabetes mellitus as determined by treating physicians
•Participation in an ongoing investigational drug or device trial that has not completed the follow-up period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the Safety of the GEM-power cable system in adult spinal deformity patients.

Secondary Outcome Measures

Name	Time	Method
clinical performance of the use of the GEM-power cable in spinal deformity surgery expressed as maintenance of spinal correction<br>evaluation of pain and quality of life

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