Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

NCT ID: NCT02683460

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

Brief Summary

This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.

This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.

Detailed Description

The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.

Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index [WOMAC]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.

Conditions

Osteoarthritis, Patella Resurfacing

Study Design

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

Study Groups

patella resurfacing group

Procedure: Patellar component Resurfacing with onlay technique

Group Type: EXPERIMENTAL

Patella resurfacing

Intervention Type: PROCEDURE

patella retention

Procedure: patellar retention Trimming of osteophytes when appropriate

Group Type: ACTIVE_COMPARATOR

Patella retention

Intervention Type: PROCEDURE

Interventions

Patella resurfacing

Intervention Type: PROCEDURE

Patella retention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients for total knee arthroplasty
• Having medicare insurance

Exclusion Criteria

• Patients who are not able to cooperate
• Serious deformity (not suitable for a standard TKA prosthesis)
• Patellar thickness less than 18 mm
• Prior operation involving the extensor mechanism
• Rheumatoid arthritis
• Severe medical disability limiting the ability to walk
• Revision surgery
• Knees with predominantly patellofemoral arthrosis

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Yong In

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong In, MD, PhD

Role: STUDY_CHAIR

the Catholic Univerisity of Korea Seoul St Mary's hospital

Central Contacts

Yong In, MD, PhD

Role: CONTACT

iy1000@catholic.ac.kr

8290445228

Mansoo Kim, MD

Role: CONTACT

kms3779@naver.com

8272333875

Other Identifiers

Patella resurfacing

Identifier Type: -

Identifier Source: org_study_id