Fast TrackNCT03823573
Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
A study testing Walk within 24 hours in people with Fast Track and Tranexamic Acid Adverse Reaction, run by Ignacio Aguado Maestro at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Fast Track, Tranexamic Acid Adverse Reaction, Knee Osteoarthritis
- What is being tested?
- Walk within 24 hours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis willing to undergo total knee arthroplasty
- Age 55-79
- Consent
Who cannot join
- Hipersensibility to any of the components used
- Epilepsy
- Pulmonary embolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital
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.
Read the 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.
- Being tested
- Walk within 24 hours
- Keywords
- fast track, total knee arthroplasty, tranexamic acid, drain
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk within 24 hoursBehavioural
Also called Drain, Discharge the day after walking
Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Walk within 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Morphine clorhydrate shots requested by the patient
Number of shots requested and administered to the patient after surgery
Measured: 24 hours
Range of Motion
Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
Measured: 6 months
Ultrasonography incidence of deep vein thrombosis
Incidence of deep vein thrombosis measured by ultrasound
Measured: 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.
Measured: 6 months
Infection
Incidence of infection
Measured: 1 year
Blood loss
Haemoglobin drop
Measured: 48 hours
Oxford Knee Score pre op and post op
Difference in Oxford Knee Scores postoperatively and preoperatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start10 Jan 2019
- Primary completion30 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fast TrackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ignacio Aguado Maestro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ignacio Aguado Maestro, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823573
- Sponsor's protocol ID
- P1102-16
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2019
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial Regarding the Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty in Rio Hortega University Hospital
- ClinicalTrials.gov ID
- NCT03823573
- Acronym / sponsor ID
- P1102-16
- Keywords
- fast track, total knee arthroplasty, tranexamic acid, drain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ignacio Aguado MaestroUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid recovery protocol | Experimental | Behavioral: Walk within 24 hoursThey will start walking the day of surgery. Levobupivacain 5mg/ml will be placed in the knee tissues. Tranexamic acid inside the knee. No drains. |
| Classic protocol | Active comparator | Behavioral: Walk within 24 hoursThey 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. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Knee osteoarthritis willing to undergo total knee arthroplasty
- Age 55-79
- Consent
Key exclusion criteria (3 listed)
- Hipersensibility to any of the components used
- Epilepsy
- Pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk within 24 hoursAlso: Drain, Discharge the day after walkingPatients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains. | Behavioural | Classic protocol, Rapid recovery protocol |
Primary outcome
Pain: Morphine clorhydrate shots requested by the patient
Time frame: 24 hours
Number of shots requested and administered to the patient after surgery
Range of Motion
Time frame: 6 months
Knee range of motion measured in degrees of flexion (0-180º and extension (0-180º)
Ultrasonography incidence of deep vein thrombosis
Time frame: 4 weeks-8 weeks
Incidence of deep vein thrombosis measured by ultrasound
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.
Infection
Time frame: 1 year
Incidence of infection
Blood loss
Time frame: 48 hours
Haemoglobin drop
Oxford Knee Score pre op and post op
Time frame: 6 months
Difference in Oxford Knee Scores postoperatively and preoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Fast Track
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
Not yet recruiting
Planned Operating-Room Extubation After Cardiac Surgery
Mechanical Ventilation, Cardiac Surgery
RecruitingObservational study
Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, and Fractional Flow Reserve Derived by Computed Tomography
Multivessel Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk within 24 hours in people with Fast Track and Tranexamic Acid Adverse Reaction, run by Ignacio Aguado Maestro at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Morphine clorhydrate shots requested by the patient (time frame: 24 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.