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

The Washington University

Status: Completed

Conditions: Post-traumatic Osteoarthritis; Osteoarthritis; Rheumatoid Arthritis

Treatments: Procedure: Cemented Tibia; Procedure: Cementless Tibia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01041937

Clohisy TKA trial-201102554

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Cemented Tibia

Active Comparator group

Description:

Assessing the clinical outcomes of the different type of fixation

Treatment:

Procedure: Cemented Tibia

Cementless Tibia

Active Comparator group

Description:

Assessing the clinical outcomes of the different type of fixation

Treatment:

Procedure: Cementless Tibia