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OpenTrials
Completed

NCT Number: NCT03823573

Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

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.

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Key information

Conditions

Fast Track Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Tranexamic Acid Adverse Reaction

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario del Río Hortega

Valladolid, 47012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk within 24 hours

Behavioral

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

Primary outcomes

  1. Pain: Morphine clorhydrate shots requested by the patient

    Time frame: 24 hours

    Number of shots requested and administered to the patient after surgery

  2. Range of Motion

    Time frame: 6 months

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

  3. Ultrasonography incidence of deep vein thrombosis

    Time frame: 4 weeks-8 weeks

    Incidence of deep vein thrombosis measured by ultrasound

  4. 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.

  5. Infection

    Time frame: 1 year

    Incidence of infection

  6. Blood loss

    Time frame: 48 hours

    Haemoglobin drop

  7. Oxford Knee Score pre op and post op

    Time frame: 6 months

    Difference in Oxford Knee Scores postoperatively and preoperatively

Sponsors and collaborators

Lead sponsor

Ignacio Aguado Maestro

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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