Adult Spinal DeformityNCT02035280
Prospective Evaluation of Elderly Deformity Surgery
An observational study of Adult Spinal Deformity, run by AO Foundation, AO Spine at 13 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Adult Spinal Deformity
- How many people
- 233 participants
- Where
- 13 sitesin 8 countries
- Study dates
- Dec 2013to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients undergoing elective surgery for spinal deformity
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
United States5 sites
University of Virginia
Charlottesville, Virginia, 22903
University of Minnesota
Minneapolis, Minnesota, 55454
New York Presbyterian - Columbia University Medical Center
New York, New York, 10032
UCSF Medical Center
San Francisco, California, 94118
Washington University Orthopedics
St Louis, Missouri, 63110
China2 sites
Queen Mary Hospital
Hong Kong
Nanjing University Medical School
Nanjing
About this study
Official title: Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study
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.
Read the 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
- Keywords
- Spine, Deformity, Fusion, Elderly, SRS-22r
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 10 weeks, 12 months, 24 months
Secondary outcomes (8)
Treatment-related adverse events
Measured: Surgery, 10 weeks, 12 months, 24 months, 5 years
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.
Measured: Baseline, 10 weeks, 12 months, 24 months, 5 years
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.
Measured: Baseline, 10 weeks, 12 months, 24 months, 5 years
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).
Measured: Baseline, 10 weeks, 12 months, 24 months, 5 years
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.
Measured: Baseline
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.
Measured: Baseline, Surgery, 24 months, 5 years
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.
Measured: Baseline, 10 weeks, 12 months, 24 months, 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2021
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Collaborators
- AO Innovation Translation Center
- Responsible party
- Sponsor
- Investigators
- Stephen Lewis, MD, Principal investigator, University of TorontoSigurd Berven, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035280
- Sponsor's protocol ID
- PEEDS
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2013
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. 2026 Jul;16(6):2601-2610. doi: 10.1177/21925682251411237. Epub 2025 Dec 27.
PubMed 41454904
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study
- ClinicalTrials.gov ID
- NCT02035280
- Acronym / sponsor ID
- PEEDS
- Conditions
- Adult Spinal Deformity
- Keywords
- Spine, Deformity, Fusion, Elderly, SRS-22r
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Collaborators
- AO Innovation Translation Center
- Study start
- Dec 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients undergoing elective surgery for spinal deformity
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute change in the Scoliosis Research Society-22 r (SRS-22r) total score
Time frame: Baseline, 10 weeks, 12 months, 24 months
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.
8 secondary outcomes
Treatment-related adverse events
Time frame: Surgery, 10 weeks, 12 months, 24 months, 5 years
Oswestry Disability Index Version 2.1a (ODI)
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
EuroQoL5 (EQ-5D).
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
Pain (back and pain)
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
Bone Mineral Density (BMD)
Time frame: Baseline
Radiological Parameters
Time frame: Baseline, Surgery, 24 months, 5 years
Animal Fluency Test
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
SRS-22r
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 41454904Campos 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. 2026 Jul;16(6):2601-2610. doi: 10.1177/21925682251411237. Epub 2025 Dec 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lewis, MD principal investigator
University of Toronto
Sigurd Berven, MD principal investigator
University of California, San Francisco
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Spinal Deformity, run by AO Foundation, AO Spine at 13 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, China, Canada, Denmark, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in the Scoliosis Research Society-22 r (SRS-22r) total score (time frame: Baseline, 10 weeks, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.