Back to resultsImplementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
Primary Purpose
Fast Track, Tranexamic Acid Adverse Reaction, Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Walk within 24 hours
Sponsored by
About this trial
This is an interventional supportive care trial for Fast Track focused on measuring fast track, total knee arthroplasty, tranexamic acid, drain
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario del Río Hortega
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rapid recovery protocol
Classic protocol
Arm 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.
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.
Outcomes
Primary Outcome Measures
Pain: Morphine clorhydrate shots requested by the patient
Number of shots requested and administered to the patient after surgery
Range of Motion
Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
Ultrasonography incidence of deep vein thrombosis
Incidence of deep vein thrombosis measured by ultrasound
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.
Infection
Incidence of infection
Blood loss
Haemoglobin drop
Oxford Knee Score pre op and post op
Difference in Oxford Knee Scores postoperatively and preoperatively
Secondary Outcome Measures
Full Information
NCT ID
NCT03823573
First Posted
January 27, 2019
Last Updated
October 1, 2023
Sponsor
Ignacio Aguado Maestro
1. Study Identification
Unique Protocol Identification Number
NCT03823573
Brief Title
Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
Official Title
Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ignacio Aguado Maestro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fast Track, Tranexamic Acid Adverse Reaction, Knee Osteoarthritis
Keywords
fast track, total knee arthroplasty, tranexamic acid, drain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid recovery protocol
Arm Type
Experimental
Arm 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.
Arm Title
Classic protocol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Walk within 24 hours
Other Intervention Name(s)
Drain, Discharge the day after walking
Intervention Description
Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
Primary Outcome Measure Information:
Title
Pain: Morphine clorhydrate shots requested by the patient
Description
Number of shots requested and administered to the patient after surgery
Time Frame
24 hours
Title
Range of Motion
Description
Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
Time Frame
6 months
Title
Ultrasonography incidence of deep vein thrombosis
Description
Incidence of deep vein thrombosis measured by ultrasound
Time Frame
4 weeks-8 weeks
Title
Overall score given by the patient to the knee replacement process
Description
Satisfaction with the protocol. Subjective measure by the patient from 0 (bad) to 10 (best) with the surgery process.
Time Frame
6 months
Title
Infection
Description
Incidence of infection
Time Frame
1 year
Title
Blood loss
Description
Haemoglobin drop
Time Frame
48 hours
Title
Oxford Knee Score pre op and post op
Description
Difference in Oxford Knee Scores postoperatively and preoperatively
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitario del Río Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
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