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Clinical Trials/NCT03823573
NCT03823573
Completed
N/A

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

Ignacio Aguado Maestro1 site in 1 country175 target enrollmentJanuary 10, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fast Track
Sponsor
Ignacio Aguado Maestro
Enrollment
175
Locations
1
Primary Endpoint
Oxford Knee Score pre op and post op
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2019
End Date
December 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ignacio Aguado Maestro
Responsible Party
Sponsor Investigator
Principal Investigator

Ignacio Aguado Maestro

Principal Investigator

Hospital del Río Hortega

Eligibility Criteria

Inclusion Criteria

  • Knee osteoarthritis willing to undergo total knee arthroplasty
  • Age 55-79

Exclusion Criteria

  • Hipersensibility to any of the components used
  • Pulmonary embolism

Outcomes

Primary Outcomes

Oxford Knee Score pre op and post op

Time Frame: 6 months

Difference in Oxford Knee Scores postoperatively and preoperatively

Range of Motion

Time Frame: 6 months

Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)

Pain: Morphine clorhydrate shots requested by the patient

Time Frame: 24 hours

Number of shots requested and administered to the patient after surgery

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.

Blood loss

Time Frame: 48 hours

Haemoglobin drop

Infection

Time Frame: 1 year

Incidence of infection

Ultrasonography incidence of deep vein thrombosis

Time Frame: 4 weeks-8 weeks

Incidence of deep vein thrombosis measured by ultrasound

Study Sites (1)

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