NCT02035280

Prospective Evaluation of Elderly Deformity Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 233 (actual)
• Sponsor: AO Foundation, AO Spine · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Spinal Deformity

Timeline

• Start date: 2013-12-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2014-01-14
• Last updated: 2023-07-28

Locations

13 sites across 8 countries: United States, Canada, China, Denmark, Japan, Netherlands, Spain, Turkey (Türkiye)