- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03606109
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
August 25, 2022 updated by: NYU Langone Health
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Not Provided
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing TTO
- Age 18-60
- Willing and able to provide consent
Exclusion Criteria:
- Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age
- Older than 60 years of age
- Any patient considered a vulnerable subject
- Have bleeding or clotting disorder
- Preoperative anticoagulation therapy
- Abnormal coagulation profile
- Renal disorder or insufficiency
- Sickle cell disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High Tibial Osteotomy (HTO)
|
One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects
|
Active Comparator: Tibial Tubercle Ostetomy (TTO)
|
One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative Blood Loss
Time Frame: Perioperative, up to 2 hours
|
Perioperative, up to 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on Visual Analogue Scale (VAS) for Pain
Time Frame: Day 1
|
VAS will be used to report post-operative pain.
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score).
The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
|
Day 1
|
Score on Visual Analogue Scale (VAS) for Pain
Time Frame: Day 4
|
VAS will be used to report post-operative pain.
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score).
The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
|
Day 4
|
Score on Visual Analogue Scale (VAS) for Pain
Time Frame: Day 7
|
VAS will be used to report post-operative pain.
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score).
The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
|
Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2018
Primary Completion (Actual)
June 2, 2021
Study Completion (Actual)
June 2, 2021
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
July 27, 2018
First Posted (Actual)
July 30, 2018
Study Record Updates
Last Update Posted (Actual)
September 21, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-00535
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tibial Tubercle Osteotomy
-
Tampere University HospitalPihlajalinna Hospital, TampereNot yet recruitingRehabilitation | Patella Alta | Tibial Tubercle Distalisation Osteotomy
-
Banff Sport Medicine FoundationCanadian Orthopaedic Foundation; CONMED CorporationRecruitingTibial Tubercle Osteotomy | Patellofemoral Dislocation | Medial Patellofemoral Ligament ReconstructionCanada
-
University of WinchesterHampshire Hospitals NHS Foundation TrustSuspendedHigh Tibial Osteotomy With Allograft Wedge | High Tibial Osteotomy Without Allograft Wedge | Pre- and Post-operative Physical Activity LevelsUnited Kingdom
-
Fowler Kennedy Sport Medicine ClinicCompletedOpening Wedge High Tibial OsteotomyCanada
-
Canisius-Wilhelmina HospitalRecruitingPatellofemoral Pain Syndrome | Tibial Tubercle Transfer | Home Exercise ProgramNetherlands
-
Peng LiuCompletedKnee Osteoarthritis | Pain Management | Total Knee Arthroplasty | Unicompartmental Knee Arthroplasty | High Tibial OsteotomyChina
-
Yonsei UniversityUnknownCorrectional OsteotomyKorea, Republic of
-
Augusta UniversityRecruiting
-
Hams Hamed AbdelrahmanCompleted
-
Cairo UniversityUnknown
Clinical Trials on Tranexamic Acid (TXA)
-
HaEmek Medical Center, IsraelWithdrawn
-
Rush University Medical CenterWithdrawnArthritis | Anemia | Total Knee Arthroplasty | Total Hip ArthroplastyUnited States
-
Boston Children's HospitalCompletedCraniosynostosisUnited States
-
NYU Langone HealthTerminated
-
Mansoura UniversityNot yet recruiting
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
Cristina MartinezCompleted
-
Rush University Medical CenterCompletedBlood Loss After Primary Total Joint Arthroplasty | Need for Blood Transfusion After Total Joint ArthroplastyUnited States
-
University of Kansas Medical CenterCompletedSarcoma,Soft Tissue | Musculoskeletal CancerUnited States
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Fraser HealthMichael Smith Foundation for Health Research; BC Support UnitCompletedUrologic Diseases | Prostate Cancer | Bladder Cancer | Urinary Retention | Patient Satisfaction | Nurse's Role | Hematuria | Nurse Physician RelationsCanada