Prospective Evaluation of Elderly Deformity Surgery

Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study

As the population continues to age, the prevalence of spinal deformity surgery for older patients is increasing. Questions regarding the suitability of these patients to undergo large spinal procedures and whether the outcomes merit the risks involved are not well known.

Study Overview

• Status: Completed
• Conditions: Adult Spinal Deformity

Detailed Description

225 subjects greater than or equal 60 years of age with moderate and severe adult spinal deformity requiring surgical correction will be enrolled in a prospective multicenter international study. Spinal deformity will be defined as any coronal or sagittal plane spinal deformity in patients who have not undergone any previous spinal surgery (with the exception of prior decompression of a maximum of 2 levels) necessitating at a minimum a 5-level spinal fusion procedure. Standard radiographs and cross sectional imaging will be performed preoperatively, postoperatively, at 24 months and 5 years after surgery. Preoperative disease specific and general health questionnaires will be completed by all patients (EQ-5D, ODI, SRS-22r, NRS for back and leg pain). Follow up visits with questionnaires will be performed at 10 weeks (± 6 weeks), 12 months (± 2 months), 24 months (± 2 months) and 5 years (±6 months) post-operatively. All treatment-related AEs will be documented.

Regression analyses will be used to evaluate the association between patient demographics, comorbidities, treatment history, spinal deformity characteristics, surgical characteristics, treatment-related AEs and pre-surgical status to self-reported and radiographic outcomes after surgery.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto Western Hospital
• China
  • Hong Kong, China
    • Queen Mary Hospital
  • Nanjing, China
    • Nanjing University Medical School
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• Japan
  • Hamamatsu, Japan
    • Hamamatsu University School of Medicine
• Netherlands
  • Nijmegen, Netherlands
    • St. Maartens Kliniek
• Spain
  • Barcelona, Spain
    • Hospital Vall d'Hebron
• Turkey
  • Istanbul, Turkey
    • Aciboden Maser Hospital
• United States
  • California
    • San Francisco, California, United States, 94118
      • UCSF Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Orthopedics
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian - Columbia University Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Elderly patients undergoing elective surgery for spinal deformity

Description

Inclusion Criteria:

• Age 60 years or older at the time of surgery
• Diagnosis of adult spinal deformity either in the coronal or sagittal plane requiring at the minimum a 5-level spinal fusion procedure
• Ability to understand the content of the patient information / Informed Consent Form
• Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
• Signed and dated Institutional Review Board (IRB)/Ethics Committee (EC)-approved written informed consent
• Reconsent of patients for the 5 year follow-up if required by the IRB/EC

Exclusion Criteria:

• Any previous spinal procedure (except prior decompression of a maximum of 2 levels)
• Neurodegenerative disease or paralysis
• Unlikely to comply with follow-up
• Institutionalized individuals
• Any not medically managed severe systemic disease
• Recent history (≤ 3 months) of substance abuse (ie, recreational drugs, alcohol) or psychosocial disturbance that would preclude reliable assessment
• Prisoner
• Presence of active malignancy
• Has active, overt bacterial infection, systemic or local
• History of recent(≤ 3 months) fracture/malignancy in the spinal region
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elderly suffering of spine deformity; Spinal deformity patients over the age of 60 years undergoing elective surgery and requiring fusion of at least 5 levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in the Scoliosis Research Society-22 r (SRS-22r) total score	The primary outcome is the absolute change in the SRS-22r total score between baseline and 24-months follow-up (FU) values in patients at age 60 or older treated with major spinal reconstruction. The SRS-22r is a patient-reported outcome instrument and has a range from 1 (worst) to 5 (best). It contains 22 questions covering five domains: function, pain, self-image, mental health (each with 5 items), and satisfaction with treatment (2 items) and each item is scored from 1 to 5.	Baseline, 10 weeks, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related adverse events		Surgery, 10 weeks, 12 months, 24 months, 5 years
Oswestry Disability Index Version 2.1a (ODI)	The outcome measure is the absolute change between baseline, the 24-month and the 5-year FU values. The ODI is a patient-reported outcome measure used most commonly in patients with low back pain. It consists of 10 questions and each of the items can be scored from 0 (no disability) to 5 (maximal disability), leading to a maximum score of 50.	Baseline, 10 weeks, 12 months, 24 months, 5 years
EuroQoL5 (EQ-5D).	The EQ-5D is a standardized instrument designed for self-completion to assess quality of life. It has 5 items with a three-point categorical response scale. A unique EQ-5D health state is defined by combining one level from each of the five dimensions. The EQ-5D is a standardized instrument designed for self-completion to assess quality of life. It has 5 items with a three-point categorical response scale. A unique EQ-5D health state is defined by combining one level from each of the five dimensions.	Baseline, 10 weeks, 12 months, 24 months, 5 years
Pain (back and pain)	The outcome measure is the absolute change between baseline,the 24-month and 5 year FU values. Lower back and leg pain will be assessed on a visual analogue scale (NRS) which ranges from 0 (no pain) to 100 (severe pain).	Baseline, 10 weeks, 12 months, 24 months, 5 years
Bone Mineral Density (BMD)	Baseline dual energy x-ray absorptiometry (DXA) scans of patients' BMD will only be performed at clinics where assessed as standard of care.	Baseline
Radiological Parameters	Radiological paramaters (lumbar lordosis, thoracic kyphosis, sagittal vertical axis, Cobb angle) will be measured at one pre- and two post-OP timepoints from sagittal standing and coronal standing x-rays.	Baseline, Surgery, 24 months, 5 years
Animal Fluency Test	The animal fluency test is a diagnostic tool that is recommended for use in clinical practice for quick assessment of cognitive impairment. The patient names as many animals as possible within a 60-second time period. Fifteen or fewer animals may indicate development of cognitive impairment.	Baseline, 10 weeks, 12 months, 24 months, 5 years
SRS-22r	The SRS-22r is a patient-reported outcome instrument and has a range from 1 (worst) to 5 (best). It contains 22 questions covering five domains: function, pain, self-image, mental health (each with 5 items), and satisfaction with treatment (2 items) and each item is scored from 1 to 5.	5 years

Collaborators and Investigators

• Sponsor: AO Foundation, AO Spine
• Collaborators: AO Innovation Translation Center
• Investigators: Principal Investigator: Stephen Lewis, MD, University of Toronto; Principal Investigator: Sigurd Berven, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimated): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Spine; Fusion; Deformity; SRS-22r
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: PEEDS