N/A
Completed N=400
Opioid-free Accelerated Recovery Total Knee Arthroplasty
Arthropathy of Knee Joint
Source: ClinicalTrials.gov NCT03647709 ↗
Enrolled (actual)
400
Serious AEs
1.0%
Results posted
May 2020
Primary outcomePrimary: Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative — 73 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative |
73 | — |
| PRIMARY Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative |
72; 159; 101; 53 | — |
| SECONDARY Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity |
1.0; 2.4; 2.9; 4.6; 1.8; 3.4 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) |
53.1; 71.8; 90.0 | — |
| SECONDARY Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement |
386 | — |
| SECONDARY Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 |
193; 64; 76; 53 | 0.0015 sig |
| SECONDARY Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 |
290; 28; 59; 7 | .6398 |
| SECONDARY Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 |
361; 10; 12; 2 | .0658 |
| SECONDARY Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 |
297; 2; 38; 0 | 1.0000 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03647709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.