Prospective Evaluation of Elderly Deformity Surgery

AO Foundation, AO Spine

Status: Completed

Conditions: Adult Spinal Deformity

Study type: Observational

Funder types: Other

Identifiers

NCT02035280

PEEDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 233 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

233 participants in 1 patient group

Elderly suffering of spine deformity

Description:

Spinal deformity patients over the age of 60 years undergoing elective surgery and requiring fusion of at least 5 levels.