Intra-articular Volumetric Assessment After Total Knee Arthroplasty
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 10/25/2017 |
| Start Date: | September 28, 2016 |
| End Date: | February 2018 |
| Contact: | Nirav H. Amin, MD |
| Email: | NHAmin@llu.edu |
| Phone: | 909-558-2808 |
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.
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.
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.
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.
Inclusion Criteria:
- Patients undergoing elective primary total knee arthroplasty.
- Patients not meeting exclusion criteria
Exclusion Criteria:
- 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
- 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.)
We found this trial at
1
site
11234 Anderson Street
Loma Linda, California 92354
Loma Linda, California 92354
Phone: 909-558-5592
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