Intra-articular Volumetric Assessment After Total Knee Arthroplasty

Hematoma Clinical Trial

— TKA  

Official title:

Intra-articular Volumetric Assessment After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821325
• Other study ID #: 5160043
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: February 22, 2018
• Start date: September 28, 2016
• Est. completion date: January 30, 2018

Study information

• Verified date: February 2018
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 #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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Hematoma

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Healthcare Department of Orthopaedic Surgery	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days