Registry for spine surgery outcomes based on patient positioning
Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
This study is testing how different positions during thoracolumbar spine surgery affect recovery and long-term results for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Spine and Scoliosis Research Associates Academic / other |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT04839783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to systematically compare surgical fusion techniques for patients undergoing thoracolumbar spinal fusion. It will assess how different patient positions during surgery impact both short-term and long-term outcomes, including revision rates. Patients will complete health and wellness surveys before and after surgery, and their surgical details, such as hardware placement and surgery duration, will be documented. Follow-up will extend up to 10 years post-operatively to gather data on any subsequent revision surgeries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are facing spinal conditions that require surgical intervention.
Not a fit: Patients who are currently incarcerated, pregnant, or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and better long-term outcomes for patients undergoing spine fusion.
How similar studies have performed: While similar observational studies have been conducted, this specific focus on patient positioning in spine surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Ability to speak and read comfortably in English 3. Affliction by a spinal condition warranting evaluation for operative treatment Exclusion Criteria: 1. Current incarceration 2. Individuals incapable of consenting and/or objectively responding to surveys, irrespective of reasonable assistance 3. Women currently pregnant or expecting to become pregnant in the near future 4. Subjects participating in another research study, whose protocol would conflict with comprehensive participation in this study 5. Subjects with psychiatric pathology which may impair judgement or the ability to give informed consent.
Where this trial is running
Boston, Massachusetts and 5 other locations
- New England Baptist Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- NYU Langone Health — New York, New York, United States (Completed)
- Atlantic Neurosurgical and Spine Specialists — Wilmington, North Carolina, United States (Recruiting)
- The Spine Clinic of Oklahoma City — Oklahoma City, Oklahoma, United States (Completed)
- Austin Spine — Austin, Texas, United States (Completed)
- Melbourne Orthopedic Group — Windsor, Victoria, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.