An observational study in Hematoma, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2018-02-26.
Sponsored by Loma Linda University · Observational
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:
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:
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.
247 studies on the registry are indexed under Hematoma; 54 are open to participants now.
This study's enrollment of 10 is below the median of 106 across 62 observational studies indexed under Hematoma.
Browse Hematoma studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Patients that will undergoing a Total Knee Arthroplasty
Exclusion Criteria:
Radiology
Other: MRI
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.
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.
Time frame: 30 days
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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