Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment

NCT05154825 | Recruiting FDA Device

• 1 other identifier: 210830
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To establish the relationship in the five critical X-ray time points during multilevel posterior column osteotomies (MPCO) spinal deformity realignment in patients with adult spinal deformity and to follow the participants longitudinally to examine any follow-up X-rays and clinical data to compare to the post-operative standing scan and pre-operative data.

Conditions

Spine; Spine Deformity

Outcome Measures

Primary Outcomes (2)

• Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles

  Data analysis will involve analysis of the change of segmentally measured Sagittal Cobbs angles in the presurgical baseline, intra-operative and post-surgical X-rays

  Baseline through end of Hospital Stay, an average of 6 weeks

• Evaluate the Change from Baseline Total Lumbar Lordosis to Post-Surgical Total Lumbar Lordosis

  Data analysis will involve analysis of the change of measured total lumbar lordosis in the presurgical baseline, intra-operative and post-surgical X-rays

  Baseline through end of Hospital Stay, an average of 6 weeks

Secondary Outcomes (2)

• Evaluation of the change of Sagittal Cobb angles in post-operative X-rays taken at follow-up appointments for the first year post surgery

  Through study completion, an average of 1 year

• Evaluation of the change of total lumbar lordosis in post-operative X-rays taken at follow-up appointments for the first year post surgery

  Through study completion, an average of 1 year

Other Outcomes (4)

• PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29 question) questionnaire

  Through study completion, an average of 1 year

• Oswestry Disability Index

  Through Study Completion, an average of 1 year

• SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire)

  Through Study Completion, an average of 1 year

Study Arms (1)

Spine Surgery Participants

Spine surgical candidates that will be receiving posterior only surgery for spinal deformity

Other: Imaging-Observational

Interventions

Imaging-Observational OTHER

Preoperative standing and supine, intraoperative pre- and post-correction, and postoperative standing imaging as well as imaging collected during follow-up exams for a year following surgery

Spine Surgery Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will be select from the UCSD Neurological Surgery Spine clinic who are candidates for Posterior Spinal Surgery involving more then 3 levels of posterior column osteotomies

You may qualify if:

• Surgical Candidate for posterior only surgery for adult spinal deformity
• Patients must require deformity correction greater than 3 levels
• Adults Between the ages of 18-80
• Decisional capacity to consent to the study
• Both Primary and revision surgeries will be included

You may not qualify if:

• \) Not meeting candidacy for posterior spine surgery

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92037, United States

RECRUITING

Related Publications (3)

• Chan AK, Lau D, Osorio JA, Yue JK, Berven SH, Burch S, Hu SS, Mummaneni PV, Deviren V, Ames CP. Asymmetric Pedicle Subtraction Osteotomy for Adult Spinal Deformity with Coronal Imbalance: Complications, Radiographic and Surgical Outcomes. Oper Neurosurg. 2020 Feb 1;18(2):209-216. doi: 10.1093/ons/opz106.

  PMID: 31214712 BACKGROUND

• Scheer JK, Osorio JA, Smith JS, Schwab F, Hart RA, Hostin R, Lafage V, Jain A, Burton DC, Bess S, Ailon T, Protopsaltis TS, Klineberg EO, Shaffrey CI, Ames CP; International Spine Study Group. Development of a Preoperative Predictive Model for Reaching the Oswestry Disability Index Minimal Clinically Important Difference for Adult Spinal Deformity Patients. Spine Deform. 2018 Sep-Oct;6(5):593-599. doi: 10.1016/j.jspd.2018.02.010.

  PMID: 30122396 BACKGROUND

• Lau D, Osorio JA, Deviren V, Ames CP. The relationship of older age and perioperative outcomes following thoracolumbar three-column osteotomy for adult spinal deformity: an analysis of 300 consecutive cases. J Neurosurg Spine. 2018 Jun;28(6):593-606. doi: 10.3171/2017.10.SPINE17374. Epub 2018 Apr 6.

  PMID: 29624129 BACKGROUND

Study Officials

• Joseph Osorio, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pete Chase, MS

CONTACT

(858) 657-7651; pchase@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 13, 2021
• Study Start: December 7, 2021
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-05

Locations

US (1)