Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study (TKA)

January 4, 2019 updated by: Washington University School of Medicine

Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study

The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial Prosthesis Study will determine whether there is a significant difference in patient-reported and measured clinical outcomes (e.g. pain, function, length of recovery, and patient satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless group) and those treated with cemented tibial prosthesis (the cement group) over the first two postoperative years. Radiographs will be assessed before surgery and at established post-operative intervals to determine if there are any significant differences between patients in the two groups and to assess the influence of component fixation on radiographic stability over time. Complication and revision rates will also be assessed for comparison.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI less than <35
  • Normal neurological function
  • Primary total knee arthroplasty (Pre operative Medial Knee Patient)
  • Patient age ≤ 70 years old

Exclusion Criteria:

  • Revision surgery
  • History of joint sepsis
  • Recent systemic corticosteroids (< 2 months prior to procedure)
  • Primary or secondary carcinoma in the last five years
  • Post operative renal transplant
  • Psychosocial disorders limiting rehabilitation
  • Previous intraarticular knee fracture
  • Over 20° valgus or varus deformity
  • Extension loss over 20°
  • Unsuitable for cruciate- substituting arthroplasty
  • Unsuitable for cementless fixation of the tibial component
  • Need for augmentation wedges or bone graft
  • Previous proximal tibial osteotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cemented Tibia
Assessing the clinical outcomes of the different type of fixation
Procedure: Cemented Tibia
Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking
Active Comparator: Cementless Tibia
Assessing the clinical outcomes of the different type of fixation
Procedure: Cementless Tibia
Assessing the clinical outcomes of the different type of fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique
Time Frame: 2014
2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Stryker Trauma GmbH

Investigators

  • Principal Investigator: John Clohisy, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clohisy TKA trial-201102554

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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