Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

Ignacio Aguado Maestro

Status: Completed

Conditions: Fast Track; Tranexamic Acid Adverse Reaction; Knee Osteoarthritis

Treatments: Behavioral: Walk within 24 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT03823573

P1102-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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175 participants in 2 patient groups

Rapid recovery protocol

Experimental group

Description:

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.

Treatment:

Behavioral: Walk within 24 hours

Classic protocol

Active Comparator group

Description:

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.

Treatment:

Behavioral: Walk within 24 hours