Arthroplasty, Replacement, KneeNCT03795805
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
A study testing total knee arthroplasty, Tourniquet limb cuff and Intaarticular lidocain in people with Arthroplasty, Replacement, Knee and Acute Kidney Injury, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Acute Kidney Injury, Tourniquets
- What is being tested?
- total knee arthroplasty, Tourniquet limb cuff and Intaarticular lidocain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 15 Mar 2018to 20 Dec 2018
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients knee arthrosis
- Required a surgical treatment with Total Knee Arthroplasty
Who cannot join
- Not accept to be in the study
- Not signed consent form
- Not having blood sample for creatinin meassure
Trial locations and contacts
1 site in 1 country.
About this study
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
Read the detailed description
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
- Being tested
- total knee arthroplasty, Tourniquet limb cuff, Intaarticular lidocain
- Medical subject headings
- Acute Kidney Injury, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
Also called TKA
Total knee arhroplasty
Tourniquet limb cuffProcedure or surgery
Tourniquet limb cuff and regular anesthesia
Intaarticular lidocainDrug
Also called lidocaine
20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
| Study group | Role | What they receive |
|---|---|---|
| TKA and Tourniquet | Other | Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg Receives: Procedure: total knee arthroplasty; Procedure: Tourniquet limb cuff |
| Intraarticular lidocain | Experimental | Total knee arthroplasty with Intaarticular lidocain Receives: Procedure: total knee arthroplasty; Drug: Intaarticular lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinin before surgery
Blood Creatinin meassure in mg/dl before surgery
Measured: Creatinin before surgery
Creatinin after surgery 1
Blood Creatinin meassure in mg/dl at 24 hours
Measured: Creatinin after surgery 1 at 24 hours
Creatinin after surgery 2
Blood Creatinin meassure in mg/dl at 48 hours
Measured: Creatinin after surgery 2 at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start15 Mar 2018
- Primary completion20 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JUAN LOPEZ VALENCIA, Instituto Mexicano del Seguro Social
- Investigators
- Avelino Colin Vázquez, MD, Principal investigator, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795805
- Sponsor's protocol ID
- R-2018-3401-053
- Status last verified
- Jan 2019
- First submitted
- 26 Dec 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share only de demographic data and trial results
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
- ClinicalTrials.gov ID
- NCT03795805
- Acronym / sponsor ID
- R-2018-3401-053
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 8 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.
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
Detailed description
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| TKA and Tourniquet | Other | Procedure: total knee arthroplasty, Procedure: Tourniquet limb cuffTotal knee arthroplasty and use of tourniquet limb cuff at 270 mmHg |
| Intraarticular lidocain | Experimental | Procedure: total knee arthroplasty, Drug: Intaarticular lidocainTotal knee arthroplasty with Intaarticular lidocain |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients knee arthrosis
- Required a surgical treatment with Total Knee Arthroplasty
Key exclusion criteria (3 listed)
- Not accept to be in the study
- Not signed consent form
- Not having blood sample for creatinin meassure
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 |
|---|---|---|
| total knee arthroplastyAlso: TKATotal knee arhroplasty | Procedure or surgery | Intraarticular lidocain, TKA and Tourniquet |
| Tourniquet limb cuffTourniquet limb cuff and regular anesthesia | Procedure or surgery | TKA and Tourniquet |
| Intaarticular lidocainAlso: lidocaine20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain) | Drug | Intraarticular lidocain |
Primary outcome
Creatinin before surgery
Time frame: Creatinin before surgery
Blood Creatinin meassure in mg/dl before surgery
Creatinin after surgery 1
Time frame: Creatinin after surgery 1 at 24 hours
Blood Creatinin meassure in mg/dl at 24 hours
Creatinin after surgery 2
Time frame: Creatinin after surgery 2 at 48 hours
Blood Creatinin meassure in mg/dl at 48 hours
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 9 Jan 2019.
- Individual participant dataSharing planned: No. We will share only de demographic data and trial results
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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.
Avelino Colin Vázquez, MD principal investigator
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty, Tourniquet limb cuff and Intaarticular lidocain in people with Arthroplasty, Replacement, Knee and Acute Kidney Injury, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 2 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 9 Jan 2019. 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 Mexico. 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?
Creatinin before surgery (time frame: Creatinin before surgery). The study lists 3 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 9 Jan 2019.