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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Post-traumatic Osteoarthritis; Osteoarthritis
• Interventions: Procedure: Cementless Tibia; Procedure: Cemented Tibia

• Registration Number: NCT01041937
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cementless Tibia	Cementless Tibia	Assessing the clinical outcomes of the different type of fixation
Cemented Tibia	Cemented Tibia	Assessing the clinical outcomes of the different type of fixation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States