Single Position Spine Surgery Registry (SPSG Registry)

Spine and Scoliosis Research Associates

Status: Enrolling

Conditions: Degenerative Disc Disease; Spine Fusion; Spinal Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT04839783

20201713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.