Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Patients undergoing total knee arthroplasty will follow two different rehabilitation protocols. In one of them, they will start walking the day of surgery and discharged on a 48 hours basis. On the other one, start walking 3 days after surgery and discharged on a 96 hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and overall complications.

Detailed Description
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Randomization will be performed concealed the day before surgery. Tranexamic acid will be used in both groups. Rapid recovery group will not be using a drain, whereas the standard protocol group will have one.

Official Title
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Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital

Conditions
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Fast Track, Tranexamic Acid Adverse Reaction, Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Walk within 24 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee osteoarthritis willing to undergo total knee arthroplasty Age 55-79 Consent Exclusion Criteria: Hipersensibility to any of the components used Epilepsy Pulmonary embolism

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid recovery protocol<br>They will start walking the day of surgery. Levobupivacain 5mg/ml will be placed in the knee tissues. Tranexamic acid inside the knee. No drains. | Behavioral: Walk within 24 hours<br>* Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.<br>* Other names: Discharge the day after walking;|
| Active Comparator: Classic protocol<br>They will start walking 3 days after surgery. Levobupivacain 5 mg/ml will be placed in the femoral nerve. Tranexamic acid inside the knee. A Redon drain will be used. | Behavioral: Walk within 24 hours<br>* Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.<br>* Other names: Discharge the day after walking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: Morphine clorhydrate shots requested by the patient | Number of shots requested and administered to the patient after surgery | 24 hours | 
| Range of Motion | Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º) | 6 months | 
| Ultrasonography incidence of deep vein thrombosis | Incidence of deep vein thrombosis measured by ultrasound | 4 weeks-8 weeks | 
| Overall score given by the patient to the knee replacement process | Satisfaction with the protocol. Subjective measure by the patient from 0 (bad) to 10 (best) with the surgery process. | 6 months | 
| Infection | Incidence of infection | 1 year | 
| Blood loss | Haemoglobin drop | 48 hours | 
| Oxford Knee Score pre op and post op | Difference in Oxford Knee Scores postoperatively and preoperatively | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fast track, total knee arthroplasty, tranexamic acid, drain