Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05154825

Conditions

Spine

Spine Deformity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Imaging-Observational

Study Details

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

Study ID

NCT05154825

Start date

Dec 7, 2021

Status verified date

May, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 1) Not meeting candidacy for posterior spine surgery

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Spine Surgery Participants

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

Interventions

Imaging-Observational

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

Primary outcome measure

  • Evaluate the Change from Baseline Sagittal Cobb angles to Post-Surgical Sagittal Cobb angles [ Time Frame: 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 [ Time Frame: Baseline through end of Hospital Stay, an average of 6 weeks ]

Central Contacts and Locations

Central contacts

Pete Chase, MS

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

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Pete Chase, MS

(858)249-0865pchase@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Dec 20, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-12-20.