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Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03823573
Enrollment
175
Registered
2019-01-30
Start date
2019-01-10
Completion date
2020-12-31
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fast Track, Knee Osteoarthritis, Tranexamic Acid Adverse Reaction

Keywords

fast track, total knee arthroplasty, tranexamic acid, drain

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.

Interventions

BEHAVIORALWalk within 24 hours

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

Sponsors

Ignacio Aguado Maestro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain: Morphine clorhydrate shots requested by the patient24 hoursNumber of shots requested and administered to the patient after surgery
Range of Motion6 monthsKnee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
Ultrasonography incidence of deep vein thrombosis4 weeks-8 weeksIncidence of deep vein thrombosis measured by ultrasound
Overall score given by the patient to the knee replacement process6 monthsSatisfaction with the protocol. Subjective measure by the patient from 0 (bad) to 10 (best) with the surgery process.
Infection1 yearIncidence of infection
Blood loss48 hoursHaemoglobin drop
Oxford Knee Score pre op and post op6 monthsDifference in Oxford Knee Scores postoperatively and preoperatively

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026