TerminatedNot Applicable

Prospective Study on Ennovate® 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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Leg pain

Timeframe: 1 year

Trial details

NCT IDNCT03507881

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-01-18

View on ClinicalTrials.gov More Spine Fusion trials