Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

NCT ID: NCT03823573

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-12-31

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.

Conditions

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Fast Track Tranexamic Acid Adverse Reaction Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rapid recovery protocol

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.

Group Type EXPERIMENTAL

Walk within 24 hours

Intervention Type BEHAVIORAL

Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.

Classic protocol

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.

Group Type ACTIVE_COMPARATOR

Walk within 24 hours

Intervention Type BEHAVIORAL

Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.

Interventions

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Walk within 24 hours

Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.

Intervention Type BEHAVIORAL

Other Intervention Names

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Drain Discharge the day after walking

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ignacio Aguado Maestro

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Aguado Maestro

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Universitario del Río Hortega

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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P1102-16

Identifier Type: -

Identifier Source: org_study_id

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