Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823573
• Other study ID #: P1102-16
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2023
• Source: Hospital del Río Hortega
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Fast Track
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Tranexamic Acid Adverse Reaction

Intervention

Behavioral:
• Walk within 24 hours
Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.

Locations

Country	Name	City	State
Spain	Hospital Universitario del Río Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Ignacio Aguado Maestro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: Morphine clorhydrate shots requested by the patient	Number of shots requested and administered to the patient after surgery	24 hours
Primary	Range of Motion	Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)	6 months
Primary	Ultrasonography incidence of deep vein thrombosis	Incidence of deep vein thrombosis measured by ultrasound	4 weeks-8 weeks
Primary	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.	6 months
Primary	Infection	Incidence of infection	1 year
Primary	Blood loss	Haemoglobin drop	48 hours
Primary	Oxford Knee Score pre op and post op	Difference in Oxford Knee Scores postoperatively and preoperatively	6 months