A Study of Comparing Patient Outcomes and Satisfaction with or without Expert Panel Review before Making a Final Decision about Surgery for Grade I Degenerative Lumbar Spondylolisthesis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009104
Sponsor Protocol Number: 17-009104
About this study
The purpose of this study is to conduct a randomized control trial comparing patient outcomes and satisfaction with or without expert panel review before making a final decision about surgery for grade I degenerative lumbar spondylolisthesis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients at least 18 years of age with symptomatic lumbar spinal stenosis and single-level grade I degenerative spondylolisthesis (3 –14 mm).
- Symptomatic spinal stenosis will be defined as radicular and/ or back pain either induced or aggravated by activity and relieved by rest in a patient with either moderately
Exclusion Criteria:
- Serious medical illness (ASA Class IV or higher)
- Spondylolysis, multilevel spondylolisthesis, or high grade spondylolisthesis
(Grade II or greater than 14 mm) - Subjects will be enrolled by participating spine surgeons who are investigators in the study. These patients will be identified within the existing practice of each surgeon. There will be no advertising or any effort to recruit patients into the study from outside the practice of a study surgeon investigator.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mohamad Bydon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available