Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

October 1, 2023 updated by: Ignacio Aguado Maestro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47012
        • Hospital Universitario del Río Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Walk within 24 hours
Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
Other Names:
  • Drain
  • Discharge the day after walking
Active Comparator: 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.
Behavioral: Walk within 24 hours
Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
Other Names:
  • Drain
  • Discharge the day after walking

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ignacio Aguado Maestro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 1, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1102-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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