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Completed

NCT Number: NCT02821325

Intra-articular Volumetric Assessment After Total Knee Arthroplasty

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Healthcare Department of Orthopaedic Surgery

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Acronym: TKA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2016
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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