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| Name | Class |
|---|---|
| AO Innovation Translation Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly patients undergoing elective surgery for spinal deformity
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Lewis, MD | University of Toronto | Principal Investigator |
| Sigurd Berven, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center | San Francisco | California | 94118 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41454904 | Derived | 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. |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| 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. | 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). | 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. | 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. | 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. | 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. | 5 years |
| Minneapolis |
| Minnesota |
| 55454 |
| United States |
| Washington University Orthopedics | St Louis | Missouri | 63110 | United States |
| New York Presbyterian - Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Toronto Western Hospital | Toronto | Ontario | Canada |
| Queen Mary Hospital | Hong Kong | China |
| Nanjing University Medical School | Nanjing | China |
| Rigshospitalet | Copenhagen | Denmark |
| Hamamatsu University School of Medicine | Hamamatsu | Japan |
| St. Maartens Kliniek | Nijmegen | Netherlands |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Aciboden Maser Hospital | Istanbul | Turkey (Türkiye) |