NCT01041937

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Post-traumatic Osteoarthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
PROCEDURE	Cemented Tibia	Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking
PROCEDURE	Cementless Tibia	Assessing the clinical outcomes of the different type of fixation

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-01-05
• Last updated: 2019-01-08

Locations

1 site across 1 country: United States