Prospective Evaluation of Elderly Deformity Surgery

Adult Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035280
• Other study ID #: PEEDS
• Status: Completed
• Start date: December 2013
• Est. completion date: December 2022

Study information

• Verified date: July 2023
• Source: AO Foundation, AO Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Spinal Deformity
• Congenital Abnormalities

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AO Foundation, AO Spine	AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Canada,  China,  Denmark,  Japan,  Netherlands,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment-related adverse events		Surgery, 10 weeks, 12 months, 24 months, 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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