Single Position Spine Surgery Registry

NCT04839783 | Terminated

• 1 other identifier: 20201713
• Study Type: observational
• Target: 234
• Locations: 2 countries
• Sites: 6

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.

Conditions

Spine Fusion; Spinal Stenosis; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (14)

• Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference

  Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Interference.

  10 years

• Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity

  Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Intensity.

  10 years

• Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression

  Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Depression.

  10 years

• Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety

  Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Anxiety.

  10 years

• Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores

  Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates less Physical Function.

  10 years

• Difference in Radiographic Measurements-Cobb Angles

  Assess the difference between pre-op and post-op measurements of Cobb Angles using available spinal x-rays for patients whose Cobb Angle was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-Fractional Curve Cobb Angles

  Assess the difference between pre-op and post-op measurements of Fractional Curve Cobb Angles using available spinal x-rays for patients whose Fractional Curve Cobb Angle was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)

  Assess the difference between pre-op and post-op measurements of C7 SVA using available spinal x-rays for patients whose C7 SVA was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)

  Assess the difference between pre-op and post-op measurements of Coronal SVA using available spinal x-rays for patients whose Coronal SVA was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-Pelvic Incidence (PI)

  Assess the difference between pre-op and post-op measurements of PI using available spinal x-rays for patients whose PI was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-Pelvic Tilt (PT)

  Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose PT was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-Lumbar Lordosis (LL)

  Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose LL was to be changed as part of their surgical plan.

  10 years

• Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)

  Assess the difference between pre-op and post-op measurements of spinal x-rays, for patients whose TPA was to be changed as part of their surgical plan.

  10 years

• Revision Incidence

  Determine the incidence of spine surgery revisions after the initial surgery.

  10 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age greater than or equal to 18 years
• Ability to speak and read comfortably in English
• Affliction by a spinal condition warranting evaluation for operative treatment

You may not qualify if:

• Current incarceration
• Individuals incapable of consenting and/or objectively responding to surveys, irrespective of reasonable assistance
• Women currently pregnant or expecting to become pregnant in the near future
• Subjects participating in another research study, whose protocol would conflict with comprehensive participation in this study
• Subjects with psychiatric pathology which may impair judgement or the ability to give informed consent.

Sponsors & Collaborators

• Spine and Scoliosis Research Associates: lead

Study Sites (6)

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Atlantic Neurosurgical and Spine Specialists

Wilmington, North Carolina, 28401, United States

Location

The Spine Clinic of Oklahoma City

Oklahoma City, Oklahoma, 73114, United States

Location

Austin Spine

Austin, Texas, 78626, United States

Location

Melbourne Orthopedic Group

Windsor, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 9, 2021
• Study Start: July 7, 2020
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (5); AU (1)