Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery:

NCT02703831 | Unknown

• 1 other identifier: 16-N0036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Scoliosis, Unspecified

Keywords

adult spine deformity; time-driven activity-based costing; three-column posterior osteotomy

Outcome Measures

Primary Outcomes (1)

• Hospitalization cost

  Total medical costs including index surgery and re-admissions over 5 years

  12 months

Secondary Outcomes (5)

• Pain scales

  6, 12, 24, 36, 48 and 60 months

• Oswestry Low Back Pain Disability Questionnaire

  6, 12, 24, 36, 48 and 60 months

• Short Form 6D

  6, 12, 24, 36, 48 and 60 months

• EurQOL 5d

  6, 12, 24, 36, 48 and 60 months

• Readmissions

  90 days

Study Arms (2)

Dual attending

ACTIVE COMPARATOR

Two attending spine surgeons during the critical portions of the surgery

Procedure: Dual attending

Single attending

PLACEBO COMPARATOR

One spine attending and an assistant during the critical portions of the surgery, The assistant can be a spine fellow, a resident or a physician's assistant.

Procedure: Single Attending

Interventions

Dual attending PROCEDURE

Two attending spine surgeons perform surgery

Dual attending

Single Attending PROCEDURE

One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.

Single attending

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a complex spine adult deformity surgery.
• instrumented posterior fusion from the thoracic spine into the pelvis, S1 or iliac wings;
• and/or any three-column posterior osteotomy, either a pedicle subtraction osteotomy or a vertebral column resection.
• Is at least 25 years of age inclusive at time of surgery.
• Is willing and able to comply with the study plan and sign the Patient Informed Consent Form

You may not qualify if:

• Has presence of active malignancy.
• Has overt or active bacterial infection, either local or systemic.
• Is mentally incompetent.
• Is a prisoner.
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• Is pregnant or plan to be pregnant during the course of the study.

Sponsors & Collaborators

• Norton Leatherman Spine Center: lead

Study Sites (1)

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Steven D Glassman, MD

  Norton Leatherman Spine Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Y Carreon, MD, MSc

CONTACT

5025847525; leah.carreon@nortonhealthcare.org

Kelly R Bratcher, RN

CONTACT

5025847525; kelly.bratcher2@nortonhealthcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 9, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2023
• Last Updated: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)