N/A
Completed N=150
Traditional vs Oral Fluid Management in Total Knee Arthroplasty
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT03719378 ↗
Enrolled (actual)
150
Serious AEs
0.8%
Results posted
Mar 2021
Primary outcomePrimary: Body Weight — -1.9; -1.6 pounds
Summary
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with physiologic and patient function as primary outcome measures after surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight |
-1.9; -1.6 | — |
| SECONDARY Knee Range of Motion |
-30.5; -26.7; -27.9; -25.5; -7.7; -4.8 | — |
| SECONDARY Leg Anthropometric (Girth) Measurements |
2.5; 2.1; 0.9; 1.6; 0.00; 0.00 | — |
| SECONDARY Number of Participants With Requiring Transfusions |
0; 1 | — |
| SECONDARY Number of Participants With Off Wound Complications Post Operative |
0; 0 | — |
| SECONDARY Number of Participants With Thromboembolic Disease |
1; 0 | — |
| SECONDARY Quadriceps Strength Measure With a Handheld Dynamometer |
-10.4; -11.2; -9.0; -9.6; -3.2; -3.8 | — |
| SECONDARY Time up and GO |
4.4; 3.3; -4.7; -4.0 | — |
| SECONDARY 30 Second STS Test |
-5.3; -4.4; -0.4; 0.3 | — |
| SECONDARY Length of the Hospitalization |
56; 63; 9; 2 | — |
| SECONDARY Number of Patients Re-admitted Post TKA |
1; 0 | — |
| SECONDARY Postoperative Pain Assessment Using Visual Analog Scale |
2.6; 2.3; 4.4; 4.5; 4.3; 4.1 | — |
| SECONDARY PONV (Post-operative Nausea and Vomiting) |
51; 46; 9; 12; 3; 3 | — |
| SECONDARY Veterans Rand -12 |
-4.7; -1.2; -8.3; -4.5; -2.5; -3.2 | — |
| SECONDARY Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) |
-1.6; 3.1; 9.4; 12.3 | — |
| SECONDARY Patient Reported Outcomes - Knee Society Score(KSS) |
-14.6; -0.2; 31.9; 40.5 | — |
| SECONDARY Total IV Fluids Received |
3895; 350 | — |
| SECONDARY Bioimpedence |
-17.8; 4.2; -41.4; -38.5; -30.9; -31.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 18-75 years old undergoing a primary total knee arthroplasty for a diagnosis of degenerative osteoarthritis who do not meet the exclusion criteria listed below
Exclusion Criteria
- Volume-dependent cardiac conditions:
- Aortic stenosis
- Pulmonary valve stenosis
- Subaortic stenosis
- Severe Aortic Insufficiency
- Chronic systolic heart failure
- Eisenmeinger Syndrome
- Severe pulmonary HTN
- Chronic or paroxysmal dysrhythmias
- Pre-operative electrolyte abnormalities
- Abnormalities of the HPA (hypothalamic-pituitary axis)
- Stage 3 Chronic Kidney Disease (or worse)
- Patients taking angiotensin receptor blockers (ARB)
- Patients with uncontrolled diabetes mellitus (patient with A1C of 7+ or on insulin)
- Patients whose BMI is > 35 38 or < 19
- Current use of long acting narcotic medication or 3 or more months of daily short acting narcotic medication
- Patients at risk for electrolyte abnormalities, dehydration or intra-operative hypotension. (patients taking angiotensin receptor blockers, ACE inhibitors (48 hours prior to surgery) and Diuretics)
- Patients with severe, untreated or uncontrolled GERD.
- Patients that cannot receive spinal anesthesia (e.g. patient with back fusions)
- Pre-Operative Anemia
Data sourced from ClinicalTrials.gov (NCT03719378). 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.