Prospective Study on EnnovateĀ® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients (NCT03507881) | Clinical Trial Compass
TerminatedNot Applicable
Prospective Study on EnnovateĀ® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients
Stopped: Recruitment too slow
Germany2 participantsStarted 2018-07-31
Plain-language summary
The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion Criteria:
* Symptomatic single-level IS (L4-S1), (VAS \> 30mm, treated conservatively for a minimum of 6 months)
* Isthmic Spondylolisthesis Meyerding grade I and II
* Signed Informed Consent of the patient regarding the participation in this study
Exclusion Criteria:
* Multilevel IS
* Severe degenerative changes of cranial adjacent level (disc height of \<50% of the next healthy segment,
* Previous lumbar spine surgery except microdiscectomy or micro- decompression of the index level
* Patients psychically or mentally not able to give or refuse consent
* Patients psychically or mentally not able to answer the questions regarding their health status and quality of life
* Pregnancy (current or planned)
* BMI \>35
* Systemic or local infection
* Chemotherapy or radiation ongoing
* Desire of early retirement (running pension request)
* All contraindications as listed in the instructions for use