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

Total Knee Replacement Clinical Trial

— PROFIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500252
• Other study ID #: Pro00002794
• Status: Completed
• Phase: Phase 4
• Start date: September 1996
• Est. completion date: December 2009

Study information

• Verified date: July 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• scheduled for primary TKA to treat non-inflammatory arthritis

• age 40- 75 years of age

Exclusion Criteria:

• history of knee sepsis

• previous patellectomy

• previous high tibial osteotomy

• knee flexion contracture of >20 degrees

• varus or valgus deformity of > 20 degrees

• < 90 degrees of knee flexion

• tibial or femoral bone deficiency requiring augmentation

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

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
• Profix TKR with Patellar Retention
All subjects received a Profix TKR. Subjects in the Patellar Retention group retained their native patellar surface.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Smith & Nephew, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative	This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).; The change score was calculated by subtracting the preoperative score from the five year score.	Preoperative to 5 years postoperative
Primary	Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative	This measures the change in patients' reported function from preoperative to 5 years postoperative.; The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).; The change score was calculated by subtracting the preoperative score from the five year score.	Preoperative to 5 years postoperative
Primary	Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative	This is the change in the patients' perceived pain between preoperative and 5 years postoperative.; The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness).; The change score was calculated by subtracting the preoperative score from the five year score.	Preoperative to 5 years postoperative
Secondary	Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative	This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).; The change score was calculated by subtracting the preoperative score from the one year score.	Preoperative to 1 year postoperative
Secondary	Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative	This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).; The change score was calculated by subtracting the preoperative score from the one year score.	Preoperative to 1 year postoperative
Secondary	Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative	This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).; The change score was calculated by subtracting the preoperative score from the one year score.	Preoperative to 1 year postoperative
Secondary	Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative	This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).; The change score was calculated by subtracting the five year score from the 10 year score.	5 years postoperative to 10 years postoperative
Secondary	Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative	This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).; The change score was calculated by subtracting the five year score from the 10 year score.	5 years postoperative to 10 years postoperative
Secondary	Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative	This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).; The change score was calculated by subtracting the five-year score from the 10 year score.	5 years postoperative to 10 years postoperative
Secondary	Number of Revision Surgeries	This measure examined the number of reoperation in the two groups of subjects	10 years