Prospective Evaluation of Elderly Deformity Surgery

NCT02035280 | Completed DMC

• 1 other identifier: PEEDS
• Study Type: observational
• Target: 233
• Locations: 8 countries
• Sites: 13

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.

Conditions

Adult Spinal Deformity

Keywords

Spine; Deformity; Fusion; Elderly; SRS-22r

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Treatment-related adverse events

  Surgery, 10 weeks, 12 months, 24 months, 5 years

• Oswestry Disability Index Version 2.1a (ODI)

  Baseline, 10 weeks, 12 months, 24 months, 5 years

• EuroQoL5 (EQ-5D).

  Baseline, 10 weeks, 12 months, 24 months, 5 years

• Pain (back and pain)

  Baseline, 10 weeks, 12 months, 24 months, 5 years

• Bone Mineral Density (BMD)

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients undergoing elective surgery for spinal deformity

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Foundation, AO Spine: lead
• AO Innovation Translation Center: collaborator

Study Sites (13)

UCSF Medical Center

San Francisco, California, 94118, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Washington University Orthopedics

St Louis, Missouri, 63110, United States

Location

New York Presbyterian - Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Queen Mary Hospital

Hong Kong, China

Location

Nanjing University Medical School

Nanjing, China

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hamamatsu University School of Medicine

Hamamatsu, Japan

Location

St. Maartens Kliniek

Nijmegen, Netherlands

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Aciboden Maser Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Campos Daziano M, Daunt L, Vashishth V, Seider E, Abbas A, Rienmueller A, Matsuyama Y, Qiu Y, Kelly M, Smith JS, Dahl BT, Spruit M, de Kleuver M, Polly DW, Sembrano J, Pellise-Urquiza F, Cheung KMC, Alanay A, Lenke LG, Shaffrey CI, Berven SH, Lewis SJ; PEEDS Study Group and AO Spine Knowledge Forum Deformity. Can Social Function Improve in Older Patients Undergoing Multi-Level Spinal Deformity Surgery? Global Spine J. 2025 Dec 27:21925682251411237. doi: 10.1177/21925682251411237. Online ahead of print.

  PMID: 41454904 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stephen Lewis, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Sigurd Berven, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 14, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

NL (1); TU (1); US (5); JP (1); DK (1); CN (2); CA (1); ES (1)