Scoliosis, Unspecified Clinical Trial
Official title:
Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery: A Cost-effectiveness Study Using Activity-based Costing
Two recent studies showed that having two attending spine surgeons performing complex adult
spine deformity surgery instead of one, decreased complications, unplanned surgeries within
30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein
thrombosis and post-operative neurologic complications [Sethi]. However, both studies were
retrospective and did not evaluate any cost-savings associated with having two spine
surgeons instead of one performing complex spine deformity surgery.
Most cost-effectiveness studies have used traditional accounting (TA) methods to determine
costs. A few cost-effectiveness studies have used time-driven activity-based costing (TDABC)
[Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery.
Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce
downstream costs compared to a single spine attending for complex spine surgeries using
traditional accounting methods; and (2) to demonstrate an application of the TDABC method to
evaluate the operating room phase during complex adult spinal deformity surgery and compare
it to traditional accounting methods (TA).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2023 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients scheduled for a complex spine adult deformity surgery. 1. instrumented posterior fusion from the thoracic spine into the pelvis, S1 or iliac wings; 2. and/or any three-column posterior osteotomy, either a pedicle subtraction osteotomy or a vertebral column resection. 2. Is at least 25 years of age inclusive at time of surgery. 3. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form Exclusion Criteria: 1. Has presence of active malignancy. 2. Has overt or active bacterial infection, either local or systemic. 3. Is mentally incompetent. 4. Is a prisoner. 5. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse. 6. Is pregnant or plan to be pregnant during the course of the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Norton Leatherman Spine Center | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Norton Leatherman Spine Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalization cost | Total medical costs including index surgery and re-admissions over 5 years | 12 months | No |
Secondary | Pain scales | Pain scales for back and leg pain (0 to 10) | 6, 12, 24, 36, 48 and 60 months | No |
Secondary | Oswestry Low Back Pain Disability Questionnaire | Low back disability | 6, 12, 24, 36, 48 and 60 months | No |
Secondary | Short Form 6D | Utility measure | 6, 12, 24, 36, 48 and 60 months | No |
Secondary | EurQOL 5d | Utility measure | 6, 12, 24, 36, 48 and 60 months | No |
Secondary | Readmissions | Number of readmissions 90 days after surgery | 90 days | No |