NCT01500252

Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial

A Randomized Clinical Trial Comparing Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty Using the PROFIX* Total Knee System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Background: Despite the excellent results of total knee replacement, also known as total knee arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface of the kneecap. Anterior knee pain, which occurs with variable and unpredictable frequency, continues to be a problem in a subset of TKA patients. Some clinicians replace the surface of all kneecaps during TKA to avoid repeat surgery, which occurs in approximately 10% of cases. However, others cite the complications attributed to replacing the surface of kneecap as reasons to avoid this procedure. This study prospectively randomized patients receiving TKA into two groups, those receiving replacement of the kneecap surface and those left without replacement of the kneecap surface to determine clinical outcomes and revisions over the first 5-10 postoperative years. Objectives: The primary objective of this work was to compare pain, stiffness and function between groups at five years postoperatively. Secondarily, we compared pain, stiffness and function at one and 10 years postoperatively. Finally, we examined the number of reoperations following TKR over 10 years in the 2 groups of subjects. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes. Methods: Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive a replacement of the kneecap surface or have no kneecap intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and 5 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and MacMaster Osteoarthritis Index \[WOMAC\]) and generic health status (Short Form 36 \[SF-36\]) questionnaire. At the end of the five year follow-up, the study was extended to a 10-year followup and the same outcomes were assessed. The revision rate was also compared between the two groups at the end of the 10-year follow-up.

Conditions

• Total Knee Replacement

Interventions

Type	Name	Description
DEVICE	Patellar Replacement Prosthesis	The Profix™ Total Knee System, a posterior cruciate retaining prosthesis manufactured by Smith and Nephew, Inc. was utilized in all subjects. Subjects randomized to the Resurfaced group received an all polyethylene patellar implant
DEVICE	Profix TKR with Patellar Retention	All subjects received a Profix TKR. Subjects in the Patellar Retention group retained their native patellar surface.

Timeline

• Start date: 1996-09-01
• Primary completion: 2004-06-01
• Completion: 2009-12-01
• First posted: 2011-12-28
• Last updated: 2021-07-27
• Results posted: 2012-05-01

Locations

1 site across 1 country: Canada