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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01041937
First received: January 4, 2010
Last updated: January 5, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis
Post-traumatic Osteoarthritis
Rheumatoid Arthritis
 Procedure: Cemented Tibia
Procedure: Cementless Tibia
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041937

Locations
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
Investigators
Principal Investigator: John Clohisy, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: John C. Clohisy, Washington University
ClinicalTrials.gov Identifier: NCT01041937     History of Changes
Other Study ID Numbers: Clohisy TKA trial
Study First Received: January 4, 2010
Last Updated: January 5, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013