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

Completed · Not applicable

Conditions studied: Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01041937

Run by

Washington University School of Medicine

People needed

106

Starts

2009-12-01

Expected to finish

2011-12-01

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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