NCT03823573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

January 27, 2019

Last Update Submit

October 1, 2023

Conditions

Fast TrackTranexamic Acid Adverse ReactionKnee Osteoarthritis

Keywords

fast tracktotal knee arthroplastytranexamic aciddrain

Outcome Measures

Primary Outcomes (7)

  • Pain: Morphine clorhydrate shots requested by the patient

    Number of shots requested and administered to the patient after surgery

    24 hours

  • Range of Motion

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

    6 months

  • Ultrasonography incidence of deep vein thrombosis

    Incidence of deep vein thrombosis measured by ultrasound

    4 weeks-8 weeks

  • 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

  • Infection

    Incidence of infection

    1 year

  • Blood loss

    Haemoglobin drop

    48 hours

  • Oxford Knee Score pre op and post op

    Difference in Oxford Knee Scores postoperatively and preoperatively

    6 months

Study Arms (2)

Rapid recovery protocol

EXPERIMENTAL

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.

Behavioral: Walk within 24 hours

Classic protocol

ACTIVE COMPARATOR

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.

Behavioral: Walk within 24 hours

Interventions

Walk within 24 hoursBEHAVIORAL

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

Also known as: Drain, Discharge the day after walking
Classic protocolRapid recovery protocol

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hipersensibility to any of the components used
  • Epilepsy
  • Pulmonary embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario del Río Hortega

Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Drainage

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2019

First Posted

January 30, 2019

Study Start

January 10, 2019

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)