Opioid-free Accelerated Recovery Total Knee Arthroplasty

NCT ID: NCT03647709

Last Updated: 2020-05-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-04-30

Brief Summary

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To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.

Detailed Description

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All study patients will receive a standardized protocol

* All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center
* Will attempt to minimize the number of anesthesiologists to further control variability in care

Methods:

1. Pre-op Optimization

* All patients enroll in education program
* All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
2. Total Joint Procedure

* Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block
3. Data Collection

* Electronic medical record chart review
* Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge
* Phone calls after discharge
* Follow-up assessment in surgeon's office
* Swift path / KOOS JR surveys
4. Pain Management Regimen

* pre-op physical therapy teaching
* post-op multimodal pain regimen

Conditions

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Arthropathy of Knee Joint

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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opioids

dosage frequency and duration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Surgeries to be performed at hospital
* Surgeries to be performed at surgery center
* Ability to read and understand English
* Primary care clearance for patients diagnosed with high blood pressure

Exclusion Criteria

* Disease states, patient conditions to exclude:

Schizophrenia Bipolar Disease Dementia

* Known allergies to local anesthetics
* Previous burn to affected extremity
* BMI \> 40
* Nonoptimized anemia
* Albumin less than 3.5
* A1C \> 8.0
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halyard Health

INDUSTRY

Sponsor Role collaborator

St. Elizabeth Medical Center, Utica, NY

OTHER

Sponsor Role lead

Responsible Party

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Dr Andrew B. Wickline

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew B Wickline, MD

Role: PRINCIPAL_INVESTIGATOR

St Elizabeth Medical Center

Locations

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St Elizabeth Medical Center

Utica, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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qllS

Identifier Type: -

Identifier Source: org_study_id

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