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

NCT ID: NCT01500252

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patellar Resurfacing

These subjects received a Profix TKR including an all polyethylene patellar implant.

Group Type: EXPERIMENTAL

Patellar Replacement Prosthesis

Intervention Type: DEVICE

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

Patellar Retention

This group received a Profix TKR, but retained their native patella

Group Type: ACTIVE_COMPARATOR

Profix TKR with Patellar Retention

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Profix TKR with Patellar Retention

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 22676495 (View on PubMed)

Other Identifiers

Pro00002794

Identifier Type: -

Identifier Source: org_study_id