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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041937
Recruitment Status : Unknown
Verified January 2010 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2010
Last Update Posted : January 6, 2010
Wright Medical Technology
Information provided by:
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Post-traumatic Osteoarthritis Rheumatoid Arthritis Procedure: Cemented Tibia Procedure: Cementless Tibia Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study
Study Start Date : December 2009
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041937

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Wright Medical Technology
Principal Investigator: John Clohisy, MD Washington University School of Medicine

Responsible Party: John C. Clohisy, Washington University Identifier: NCT01041937     History of Changes
Other Study ID Numbers: Clohisy TKA trial
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: January 6, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases