Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

Osteoarthritis, Patella Resurfacing Clinical Trial

Official title:

Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02683460
• Other study ID #: Patella resurfacing
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 16, 2016
• Start date: February 2016

Study information

• Verified date: February 2016
• Source: The Catholic University of Korea
• Contact: Yong In, MD, PhD
• Phone: 8290445228
• Email: iy1000[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Patella Resurfacing

Intervention

Procedure:
• Patella resurfacing

• Patella retention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale		Change from preoperative score to postoperative 2 years	No
Primary	Knee Society score		Change from preoperative score to postoperative 2 years	No
Secondary	Feller's score		Change from preoperative score to postoperative 2 years	No
Secondary	Patients satisfaction using Visual Analog Score for pain		Change from preoperative score to postoperative 2 years	No