HematomaTKANCT02821325
Intra-articular Volumetric Assessment After Total Knee Arthroplasty
An observational study of Hematoma, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of the study: is to quantify the amount of post-operative effusion or hematoma present after total knee arthroplasty pre-operatively, post-operative day #0,1. Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at the following times: Pre-operatively Post-operative day… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hematoma
- What is being tested?
- MRI
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2016to 30 Jan 2018
- Phase
- Observational
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that will undergoing a Total Knee Arthroplasty
Who may be able to join
- Patients undergoing elective primary total knee arthroplasty.
- Patients not meeting exclusion criteria
Who cannot join
- If patient is not able to undergo MRI
- Heart pacemaker
- Cochlear implant
- Metallic foreign body (metal silver) in the eyes
- Aneurysm clip in the brain
- Patient with prior reaction or contra-indication to tranexamic acid
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- Inability to comprehend consent process
- Age <18 or > 89
- Patient planned for outpatient procedure
- Active malignancy
- Patients with hematologic disorders (hemophilia, factor V Leiden, etc.)
- Patients with any condition that makes undergoing a MRI painful (severe spine degenerative disease, vertigo, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Healthcare Department of Orthopaedic Surgery
Loma Linda, California, 92354
About this study
The purpose of the study: is to quantify the amount of post-operative effusion or hematoma present after total knee arthroplasty pre-operatively, post-operative day #0,1.
Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at the following times:
Read more
- Pre-operatively
- Post-operative day #1 (approximately 16-20 hours post op)
- Post-operative day #2 (approximately 36-40 hours post op) This will be conducted by the Loma Linda radiology department as per normal protocols. No special imaging procedures will be undertaken.
Subjects will be both male and females, they will be patients from the Principle Investigator and Co-Investigators practice. Subjects will be between the ages of 18-89 years of age.
The total participation will last approximately 30 days.
Subject selection will be approximately 10 English speaking, both male and female between the ages of 18 to 89 years of age. Subjects will be recruited from the Principal Investigators and Co-Investigators clinic. There will be no advertising or electronic recruiting. The study is expected to last 12 months.
Read the detailed description
STUDY DESIGN:
Background or rationale for this study:
Total knee arthroplasty is one of the most successful orthopedic surgeries performed in the United States, and consistently has shown to have excellent outcomes for patients, with low complication rates. However, when complications do happen, they can range from superficial infection to repeated deep infection requiring prosthesis exchange or amputation. Another significant complication of total knee arthroplasty is joint stiffness. Range of motion loss can also be an extremely debilitating complication necessitating prolonged physical therapy, return to the operating theater for manipulation or even total synovectomy and polyethylene exchange.
Although it is currently known that post-operative hematoma leads to adverse outcomes following total knee arthroplasty, there is currently no literature to quantify the average size or progression of the intra-articular bleeding post operatively. It would be reasonable to assume that all patients develop a slight hematoma post operatively. The investigator aims to assess the size, and possible progression of the intra-articular hematoma following total knee arthroplasty.
OBJECTIVES:
The investigator aims to:
Quantify the amount of post-operative effusion or hematoma present after total knee arthroplasty pre-operatively, post-operative day #0, 1.
Procedures involved (Research Interventions)
Patients undergoing a total knee arthroplasty will undergo an MRI of the operative knee at the following times:
- Pre-operatively
- Post-operative day #1 (approximately 16-20 hours post op)
- Post-operative day #2 (approximately 36-40 hours post op)
This will be conducted by the Loma Linda radiology department as per normal protocols. No special imaging procedures will be undertaken.
No changes in operative technique or post-operative protocol will be undertaken due to study apart from the above imaging.
All imaging will be kept on the LLUMC PACS system. Concise review of literature that supports the rationale, objectives, and methodology of the proposed study.
- Conditions
- Hematoma
- Being tested
- MRI
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Patients undergoing a total knee arthroplasty, will undergo additional MRI's. One MRI pre-operatively.
2nd MRI post-operatively on day 1. 3rd MRI post-operatively on day 2.
| Study group | Role | What they receive |
|---|---|---|
| MRI | Radiology Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with total knee arthroplasty assessed for intra-articular hematoma
MRI studies will be reviewed on these participants pre-operatively and postoperatively. Data will be analyzed using the Statistical package for social sciences (SPSS) software and paired T-Test will be utilized for significance regarding the effusion post operatively.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start28 Sep 2016
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Nirav Amin, MD, Loma Linda University
- Investigators
- Nirav H. Amin, MD, Principal investigator, Loma Linda University Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821325
- Sponsor's protocol ID
- 5160043
- Acronym
- TKA
- Status last verified
- Feb 2018
- First submitted
- 25 Apr 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sex and gender. The size of the implant placed during the TKA. Indication for operative procedure. Laterality of the procedure. Operative time. Blood Loss from surgery. Range of motion at week 2 post-operatively. Range of motion at week 6 post-operatively. Any complications that develop within 30 days of the surgery. There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Volumetric Assessment After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02821325
- Acronym / sponsor ID
- TKA / 5160043
- Conditions
- Hematoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 1 Jul 2016 (estimated)
- 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.
The purpose of the study: is to quantify the amount of post-operative effusion or hematoma present after total knee arthroplasty pre-operatively, post-operative day #0,1.
Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at the following times:
- Pre-operatively
- Post-operative day #1 (approximately 16-20 hours post op)
- Post-operative day #2 (approximately 36-40 hours post op) This will be conducted by the Loma Linda radiology department as per normal protocols. No special imaging procedures will be undertaken.
Subjects will be both male and females, they will be patients from the Principle Investigator and Co-Investigators practice. Subjects will be between the ages of 18-89 years of age.
The total participation will last approximately 30 days.
Subject selection will be approximately 10 English speaking, both male and female between the ages of 18 to 89 years of age. Subjects will be recruited from the Principal Investigators and Co-Investigators clinic. There will be no advertising or electronic recruiting. The study is expected to last 12 months.
Detailed description
STUDY DESIGN:
Background or rationale for this study:
Total knee arthroplasty is one of the most successful orthopedic surgeries performed in the United States, and consistently has shown to have excellent outcomes for patients, with low complication rates. However, when complications do happen, they can range from superficial infection to repeated deep infection requiring prosthesis exchange or amputation. Another significant complication of total knee arthroplasty is joint stiffness. Range of motion loss can also be an extremely debilitating complication necessitating prolonged physical therapy, return to the operating theater for manipulation or even total synovectomy and polyethylene exchange.
Although it is currently known that post-operative hematoma leads to adverse outcomes following total knee arthroplasty, there is currently no literature to quantify the average size or progression of the intra-articular bleeding post operatively. It would be reasonable to assume that all patients develop a slight hematoma post operatively. The investigator aims to assess the size, and possible progression of the intra-articular hematoma following total knee arthroplasty.
OBJECTIVES:
The investigator aims to:
Quantify the amount of post-operative effusion or hematoma present after total knee arthroplasty pre-operatively, post-operative day #0, 1.
Procedures involved (Research Interventions)
Patients undergoing a total knee arthroplasty will undergo an MRI of the operative knee at the following times:
- Pre-operatively
- Post-operative day #1 (approximately 16-20 hours post op)
- Post-operative day #2 (approximately 36-40 hours post op)
This will be conducted by the Loma Linda radiology department as per normal protocols. No special imaging procedures will be undertaken.
No changes in operative technique or post-operative protocol will be undertaken due to study apart from the above imaging.
All imaging will be kept on the LLUMC PACS system. Concise review of literature that supports the rationale, objectives, and methodology of the proposed study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | – | Other: MRIRadiology |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that will undergoing a Total Knee Arthroplasty
Key inclusion criteria (2 listed)
- Patients undergoing elective primary total knee arthroplasty.
- Patients not meeting exclusion criteria
Key exclusion criteria (12 listed)
- If patient is not able to undergo MRI
- Heart pacemaker
- Cochlear implant
- Metallic foreign body (metal silver) in the eyes
- Aneurysm clip in the brain
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 |
|---|---|---|
| MRIPatients undergoing a total knee arthroplasty, will undergo additional MRI's. One MRI pre-operatively. 2nd MRI post-operatively on day 1. 3rd MRI post-operatively on day 2. | Other | MRI |
Primary outcome
Participants with total knee arthroplasty assessed for intra-articular hematoma
Time frame: 30 days
MRI studies will be reviewed on these participants pre-operatively and postoperatively. Data will be analyzed using the Statistical package for social sciences (SPSS) software and paired T-Test will be utilized for significance regarding the effusion post operatively.
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 26 Feb 2018.
- Individual participant dataSharing planned: Yes. Sex and gender. The size of the implant placed during the TKA. Indication for operative procedure. Laterality of the procedure. Operative time. Blood Loss from surgery. Range of motion at week 2 post-operatively. Range of motion at week 6 post-operatively. Any complications that develop within 30 days of the surgery. There is no plan to make individual participant data available.
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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.
Nirav H. Amin, MD principal investigator
Loma Linda University Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematoma, run by Loma Linda University at 1 site in United States.
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 12 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 26 Feb 2018. 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 United States. 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?
Participants with total knee arthroplasty assessed for intra-articular hematoma (time frame: 30 days). 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 26 Feb 2018.