Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Patella Resurfacing
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patella resurfacing
Patella retention
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Patella Resurfacing
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patella resurfacing group
patella retention
Arm Description
Procedure: Patellar component Resurfacing with onlay technique
Procedure: patellar retention Trimming of osteophytes when appropriate
Outcomes
Primary Outcome Measures
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
Knee Society score
Secondary Outcome Measures
Feller's score
Patients satisfaction using Visual Analog Score for pain
Full Information
NCT ID
NCT02683460
First Posted
February 4, 2016
Last Updated
February 16, 2016
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02683460
Brief Title
Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Patella Resurfacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patella resurfacing group
Arm Type
Experimental
Arm Description
Procedure: Patellar component Resurfacing with onlay technique
Arm Title
patella retention
Arm Type
Active Comparator
Arm Description
Procedure: patellar retention Trimming of osteophytes when appropriate
Intervention Type
Procedure
Intervention Name(s)
Patella resurfacing
Intervention Type
Procedure
Intervention Name(s)
Patella retention
Primary Outcome Measure Information:
Title
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale
Time Frame
Change from preoperative score to postoperative 2 years
Title
Knee Society score
Time Frame
Change from preoperative score to postoperative 2 years
Secondary Outcome Measure Information:
Title
Feller's score
Time Frame
Change from preoperative score to postoperative 2 years
Title
Patients satisfaction using Visual Analog Score for pain
Time Frame
Change from preoperative score to postoperative 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong In, MD, PhD
Phone
8290445228
Email
iy1000@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Mansoo Kim, MD
Phone
8272333875
Email
kms3779@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong In, MD, PhD
Organizational Affiliation
the Catholic Univerisity of Korea Seoul St Mary's hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
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