Clinical trial NCT01500252: Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial
Official title: A Randomized Clinical Trial Comparing Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty Using the PROFIX* Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Replacement
Keywords: Total Knee Replacement
Patellar Resurfacing
Health Related Quality of Life
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2011-12-28
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative
timeFrame: Preoperative to 5 years postoperative
measure: Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative
timeFrame: Preoperative to 5 years postoperative
measure: Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative
timeFrame: Preoperative to 5 years postoperative
Secondary outcomes:
measure: Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative
timeFrame: Preoperative to 1 year postoperative
measure: Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative
timeFrame: Preoperative to 1 year postoperative
measure: Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative
timeFrame: Preoperative to 1 year postoperative
measure: Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative
timeFrame: 5 years postoperative to 10 years postoperative
measure: Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative
timeFrame: 5 years postoperative to 10 years postoperative
measure: Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative
timeFrame: 5 years postoperative to 10 years postoperative
measure: Number of Revision Surgeries
timeFrame: 10 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
citation: Beaupre L, Secretan C, Johnston DW, Lavoie G. A randomized controlled trial comparing patellar retention versus patellar resurfacing in primary total knee arthroplasty: 5-10 year follow-up. BMC Res Notes. 2012 Jun 7;5:273. doi: 10.1186/1756-0500-5-273.