Single Position Spine Surgery Registry

Degenerative Disc Disease Clinical Trial

— SPSG Registry  

Official title:

Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839783
• Other study ID #: 20201713
• Status: Recruiting
• Start date: July 7, 2020
• Est. completion date: July 7, 2032

Study information

• Verified date: November 2023
• Source: Spine and Scoliosis Research Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 7, 2032
• Est. primary completion date: July 7, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spine Fusion

Locations

Country	Name	City	State
Australia	Melbourne Orthopedic Group	Windsor	Victoria
United States	Austin Spine	Austin	Texas
United States	New England Baptist Hospital	Boston	Massachusetts
United States	NYU Langone Health	New York	New York
United States	The Spine Clinic of Oklahoma City	Oklahoma City	Oklahoma
United States	Atlantic Neurosurgical and Spine Specialists	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Spine and Scoliosis Research Associates

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Revision Incidence	Determine the incidence of spine surgery revisions after the initial surgery.	10 years