Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Tranexamic Acid Adverse Reaction; Knee Osteoarthritis; Fast Track
• Interventions: Behavioral: Walk within 24 hours

• Registration Number: NCT03823573
• Lead Sponsor: Ignacio Aguado Maestro

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-10
• Study First Submitted: 2019-01-27
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-01
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid recovery protocol	Walk within 24 hours	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.
Classic protocol	Walk within 24 hours	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario del Río Hortega; 🇪🇸 Valladolid, Spain