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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: Cemented Tibia
* Procedure: Cementless Tibia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 2014 |