Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017. The inclusion period will be 12 months and the follow-up 24 months
Study Type
OBSERVATIONAL
Enrollment
5
Posterior mini-invasive osteosynthesis
Hopital la Timone
Marseille, France
Spinal stability
To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.
Time frame: 12 months postoperatively
Spinal fusion
Radiological assessment of bony fusion
Time frame: 12 months postoperatively
Adverse events
To quantify and describe adverse events
Time frame: During surgery, 1-6 months, 12 months, 24 months postoperatively
Disability
To assess patients' disability through ODI questionnaire
Time frame: 1-6 months, 12 months, 24 months postoperatively
Patient satisfaction index
To assess patient satisfaction after surgery using a questionnaire
Time frame: 1-6 months, 12 months, 24 months postoperatively
Pain
To assess patient's pain using visual analogue scale
Time frame: 1-6 months, 12 months, 24 months postoperatively
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