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

Spine Deformity Clinical Trial

Official title:

Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment: Preoperative Standing and Supine, Intraoperative Pre- and Post-correction, and Postoperative Standing Films

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05154825
• Other study ID #: 210830
• Status: Recruiting
• Start date: December 7, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: Pete Chase, MS
• Phone: (858) 249-0865
• Email: pchase[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Studies in adult spinal deformity (ASD) have found that the presence of sagittal imbalance directly correlates with worsening quality of life. Multilevel posterior column osteotomies (MPCOs) is a technique that can provide correction to adult spinal deformity. MPCOs can be utilized for revision surgery as an alternative to 3-column osteotomies and have the ability to aggregate large amount of lordosis segmentally. The success of the MPCO technique largely depends on radiographs taken during these surgeries to aid the surgeon in establishing the best screw and rod placement and making intraoperative adjustments. Imaging plays a vital role in evaluating hardware positioning and assessing hardware integrity as well as evaluating potential complication. The investigator plans to evaluate and establish the relationship in the five critical X-ray time points (preoperative standing and supine, intraoperative pre- and post-correction, and postoperative standing films) during MPCO spinal deformity realignment and measure pre- to post-operative outcome longitudinally. The investigator will investigate lumbar lordosis and sagittal and coronal alignment at those 5 time points and examine the relationship between pre-op, intra-op, and post-op images to understand impact of the MPCO technique and examine expected outcome to final outcome. Additionally, if the O-Arm 2D long film scanner is utilized during the surgery, the investigator will analyze that film and compare it to the other X-rays taken.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spine
• Spine Deformity

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & 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 (Hagerstown). 2020 Feb 1;18(2):209-216. doi: 10.1093/ons/opz106. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29 question) questionnaire	The PROMIS-29 will be given to assess change over time in global physical, mental and social health.	Through study completion, an average of 1 year
Other	Oswestry Disability Index	The Oswestry Disability Index will be given to assess change over time in functional disability	Through Study Completion, an average of 1 year
Other	SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire)	The SRS-22r (Scoliosis Research Society Patient Outcome Questionnaire) will be given to assess change in the health related quality of life specific to spinal deformity	Through Study Completion, an average of 1 year
Other	Visual Analog Scale (VAS) Low Back and/or Leg	The Visual Analog Scale (VAS) for Low Back and/or Leg will be given to assess changes in pain level.	Through Study Completion, an average of 1 year
Primary	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
Primary	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	Evaluation of the change of Sagittal Cobb angles in post-operative X-rays taken at follow-up appointments for the first year post surgery	Data analysis will involve analysis of the post-surgical X-rays utilizing the Sagittal Cobb angles measured segmentally	Through study completion, an average of 1 year
Secondary	Evaluation of the change of total lumbar lordosis in post-operative X-rays taken at follow-up appointments for the first year post surgery	Data analysis will involve analysis of the post-surgical X-rays utilizing the angle for lumbar lordosis	Through study completion, an average of 1 year