Phase
Condition
N/ATreatment
Pedicle fixation surgery
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system
Patient of 18 years old and more
Patient has provided signed informed consent or did not oppose to his/her datacollection, per local regulation
Exclusion
Exclusion Criteria: contra-indication
trauma (i.e., fracture or dislocation)
Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)
Any other medical or surgical condition likely to compromise the success ofinstrumented surgery, such as the presence of a malignant tumor or seriouscongenital abnormalities, raised erythrocyte sedimentation rate not explained byother diseases, high white blood cell count or a tendency to low white blood cellcount
All cases not described in the indications
Localized infection of the operative site
All patients with insufficient tissue cover of the operative site
Local signs of inflammation
Fever or leukocytosis
Pathological obesity
Pregnancy
Mental illness
Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis.Osteoporosis is a relative contraindication, as this medical condition can limit theexpected correction gain and stability of mechanical fixation
All cases not requiring bone graft or bone fusion
When pedicular screws are used, absence or malformation of pedicles
All cases requiring a combination of different metals
All patients not agreeing to comply with post-operative instructions
Study Design
Study Description
Connect with a study center
DOSCEA Pôle Rachis
Bayonne, 64100
FranceActive - Recruiting
Clinique du dos Bordeaux-Terrefort
Bruges, 33520
FranceActive - Recruiting
Orthéo Neurochirurgie
Saint-Etienne, 42199
FranceActive - Recruiting
Orthéo Neurochirurgie
Saint-Étienne, 42199
FranceSite Not Available

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