Prospective Evaluation of Elderly Deformity Surgery

• ClinicalTrials.gov Identifier: NCT02035280
• Recruitment Status: Active, not recruiting
• First Posted: January 14, 2014
• Last Update Posted: January 13, 2020
• Sponsor: AOSpine International
• Collaborator: AOCID
• Information provided by (Responsible Party): AOSpine International

Study Description

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.

Condition or disease
Adult Spinal Deformity

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

• Study Type: Observational
• Actual Enrollment: 233 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study
• Study Start Date: December 2013
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Treatment-related adverse events [ Time Frame: Surgery, 10 weeks, 12 months, 24 months, 5 years ]
2. Oswestry Disability Index Version 2.1a (ODI) [ Time Frame: Baseline, 10 weeks, 12 months, 24 months, 5 years ]

   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.

3. EuroQoL5 (EQ-5D). [ Time Frame: Baseline, 10 weeks, 12 months, 24 months, 5 years ]

   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.

4. Pain (back and pain) [ Time Frame: Baseline, 10 weeks, 12 months, 24 months, 5 years ]

   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).

5. Bone Mineral Density (BMD) [ Time Frame: Baseline ]
   Baseline dual energy x-ray absorptiometry (DXA) scans of patients' BMD will only be performed at clinics where assessed as standard of care.
6. Radiological Parameters [ Time Frame: Baseline, Surgery, 24 months, 5 years ]
   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.
7. Animal Fluency Test [ Time Frame: Baseline, 10 weeks, 12 months, 24 months, 5 years ]
   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.
8. SRS-22r [ Time Frame: 5 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Elderly patients undergoing elective surgery for spinal deformity

Criteria

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

Contacts and Locations

Locations

United States, California

UCSF Medical Center

San Francisco, California, United States, 94118

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55454

United States, Missouri

Washington University Orthopedics

Saint Louis, Missouri, United States, 63110

United States, New York

New York Presbyterian - Columbia University Medical Center

New York, New York, United States, 10032

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

Canada, Ontario

Toronto Western Hospital

Toronto, Ontario, Canada

China

Queen Mary Hospital

Hong Kong, China

Nanjing University Medical School

Nanjing, China

Denmark

Rigshospitalet

Copenhagen, Denmark

Japan

Hamamatsu University School of Medicine

Hamamatsu, Japan

Netherlands

St. Maartens Kliniek

Nijmegen, Netherlands

Spain

Hospital Vall d'Hebron

Barcelona, Spain

Turkey

Aciboden Maser Hospital

Istanbul, Turkey

Sponsors and Collaborators

AOSpine International

AOCID

Investigators

• Principal Investigator: Stephen Lewis, MD; University of Toronto
• Principal Investigator: Sigurd Berven, MD; University of California, San Francisco

More Information

• Responsible Party: AOSpine International
• ClinicalTrials.gov Identifier: NCT02035280
• Other Study ID Numbers: PEEDS
• First Posted: January 14, 2014
• Last Update Posted: January 13, 2020
• Last Verified: December 2018

Keywords provided by AOSpine International:

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

Additional relevant MeSH terms:

Congenital Abnormalities