Clinical trial NCT04839783: Single Position Spine Surgery Registry
Official title: Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spine Fusion
Spinal Stenosis
Degenerative Disc Disease
Lead sponsor: Spine and Scoliosis Research Associates
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from spinal conditions for which a spine surgeon has recommended an anterior posterior fusion, who meet all inclusion and no exclusion criteria.

Brief summary: The purpose of this study is to systematically, prospectively compare surgical fusion techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and revision rates following surgery.

Detailed description: The goal of this study is to understand how the difference in positioning of a patient intraoperatively, as part of performing an anterior posterior spine fusion surgery, can affect short term and long term outcomes. This will be accomplished through observational techniques that will not affect the care patients will receive for their spinal conditions.

Patients will be asked to complete health and wellness surveys before and after survey to determine how they are doing before surgery and then what if any changes their respective surgeries have had on their lives. Further spine x-rays that they have taken to plan their surgeries and assess their recovery will be measured, when available. X-rays will not be taken only for research purposes. Additionally aspects of their surgeries will be noted such as where hardware is placed and how long different parts of the surgery took.

Follow-up is planned to be out to 10 years post-operatively with the goal of collecting information about any revision spine surgeries that would happen during those 10 years as well.

Eligibility 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.

Primary outcomes:
measure: Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference
timeFrame: 10 years
measure: Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
timeFrame: 10 years
measure: Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression
timeFrame: 10 years
measure: Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety
timeFrame: 10 years
measure: Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores
timeFrame: 10 years
measure: Difference in Radiographic Measurements-Cobb Angles
timeFrame: 10 years
measure: Difference in Radiographic Measurements-Fractional Curve Cobb Angles
timeFrame: 10 years
measure: Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)
timeFrame: 10 years
measure: Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)
timeFrame: 10 years
measure: Difference in Radiographic Measurements-Pelvic Incidence (PI)
timeFrame: 10 years
measure: Difference in Radiographic Measurements-Pelvic Tilt (PT)
timeFrame: 10 years
measure: Difference in Radiographic Measurements-Lumbar Lordosis (LL)
timeFrame: 10 years
measure: Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)
timeFrame: 10 years
measure: Revision Incidence
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Wilmington
country: United States
facility: Atlantic Neurosurgical and Spine Specialists
state: North Carolina
city: Oklahoma City
country: United States
facility: The Spine Clinic of Oklahoma City
state: Oklahoma
city: Austin
country: United States
facility: Austin Spine
state: Texas
city: Windsor
country: Australia
facility: Melbourne Orthopedic Group
state: Victoria
Study officials:
References: