Clinical trial NCT02035280: Prospective Evaluation of Elderly Deformity Surgery
Official title: Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Spinal Deformity
Keywords: Spine
Deformity
Fusion
Elderly
SRS-22r
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
Collaborators: name: AO Innovation Translation Center
First posted: 2014-01-14
Enrollment: 233
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients undergoing elective surgery for spinal deformity

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Absolute change in the Scoliosis Research Society-22 r (SRS-22r) total score
timeFrame: Baseline, 10 weeks, 12 months, 24 months
Secondary outcomes:
measure: Treatment-related adverse events
timeFrame: Surgery, 10 weeks, 12 months, 24 months, 5 years
measure: Oswestry Disability Index Version 2.1a (ODI)
timeFrame: Baseline, 10 weeks, 12 months, 24 months, 5 years
measure: EuroQoL5 (EQ-5D).
timeFrame: Baseline, 10 weeks, 12 months, 24 months, 5 years
measure: Pain (back and pain)
timeFrame: Baseline, 10 weeks, 12 months, 24 months, 5 years
measure: Bone Mineral Density (BMD)
timeFrame: Baseline
measure: Radiological Parameters
timeFrame: Baseline, Surgery, 24 months, 5 years
measure: Animal Fluency Test
timeFrame: Baseline, 10 weeks, 12 months, 24 months, 5 years
measure: SRS-22r
timeFrame: 5 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Orthopedics
state: Missouri
city: New York
country: United States
facility: New York Presbyterian - Columbia University Medical Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Nanjing
country: China
facility: Nanjing University Medical School
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
city: Nijmegen
country: Netherlands
facility: St. Maartens Kliniek
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Istanbul
country: Turkey
facility: Aciboden Maser Hospital
Study officials:
affiliation: University of Toronto
name: Stephen Lewis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sigurd Berven, MD
role: PRINCIPAL_INVESTIGATOR
References: