Intra-articular Volumetric Assessment After Total Knee Arthroplasty

NCT02821325 | Completed

• 1 other identifier: 5160043
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI

Radiology

Other: MRI

Interventions

MRI OTHER

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.

MRI

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that will undergoing a Total Knee Arthroplasty

You may qualify if:

• Patients undergoing elective primary total knee arthroplasty.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Loma Linda University: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Loma Linda University Healthcare Department of Orthopaedic Surgery

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Hematoma

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nirav H. Amin, MD

  Loma Linda University Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: July 1, 2016
• Study Start: September 28, 2016
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)