Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
Primary Purpose
Osteo Arthritis Knee, Knee Pain Chronic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring anterior knee pain, gender knee prosthesis, patellar tracking, unisex knee prosthesis, total knee arthroplasty, patellar resurfacing
Eligibility Criteria
Inclusion Criteria:
Aymptomatic knee OA with
- varus deformity < 30 degrees
- range of motion > 90 degrees
- flexion contracture < 20 degrees
- recurvatum < 20 degrees
Exclusion Criteria:
- gout
- postraumatic arthritis
- osteonecrosis of knee
- inflammatory joint disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patient specific knee prosthesis
Unisex knee prosthesis
Arm Description
TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
Outcomes
Primary Outcome Measures
anterior knee pain
Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)
patellar tracking
patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking
Secondary Outcome Measures
clinical outcome score
knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)
Full Information
NCT ID
NCT05045651
First Posted
August 29, 2021
Last Updated
September 12, 2021
Sponsor
Thammasat University
1. Study Identification
Unique Protocol Identification Number
NCT05045651
Brief Title
Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
Official Title
The Incidence of Anterior Knee Pain Between Unisex Knee Prosthesis and Gender Specific Knee Prosthesis Following Minimally Invasive Surgery Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking
Detailed Description
Background:The anterior knee pain (AKP) is one of major problem of TKA. The incidence of anterior knee after TKA was 4% to 49%. The cause of AKP after TKA from surgical technique errors including joint line elevation, instability, malalignment of prosthesis, and maltracking of patella. However, AKP still has presented even high volume surgeon that prosthesis had good alignment and good stability, one of the risk factor is female. Due to female has higher Q-angle, greater anteroposterior (AP)/mediolateral(ML) ratio, smaller anterior condyle, and trochlea has higher degree of valgus angle than male. Therefore, female should has AKP even surgery with good surgical technique. The gender specific knee prosthesis was design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. For these reasons, the gender specific knee prosthesis should reduce AKP and improve patellar tracking in female. And there is no study to compare AKP and patellar tracking between Unisex knee prosthesis and gender specific knee prosthesis following minimally invasive surgery (MIS) TKA.
Investigators asked whether AKP and patellar tracking differ between unisex knee prosthesis and gender specific knee prosthesis following MIS TKA with patellar resurfacing.
Methods:The participants were randomized into 2 groups (Gp) with computer program to make a list of random numbers of participant. Gp1 was gender specific knee prosthesis; consisted of 40 participants (40 knees) and Gp2 was unisex knee prosthesis; consisted of 40 participants (40 knees). The sample size was calculate base on anterior knee pain after TKA with a risk difference of 27% (3% versus 20%) (1,3). The 40 participants from each group would have 90% power at the 5% significant level.
Patrticipants were follow up at 2 wks, 6 wks, 3 mo, 6mo, 1 year and 2 years. At each follow up, the % anterior knee pain, VAS for anterior knee pain were record. The knee society score also was recorded and compared between two group.
All participants were operated with same surgeon and same instrumentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Knee Pain Chronic
Keywords
anterior knee pain, gender knee prosthesis, patellar tracking, unisex knee prosthesis, total knee arthroplasty, patellar resurfacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient specific knee prosthesis
Arm Type
Experimental
Arm Description
TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
Arm Title
Unisex knee prosthesis
Arm Type
Experimental
Arm Description
TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
Intervention Type
Procedure
Intervention Name(s)
Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA
Intervention Description
gender specific knee prosthesis:design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. The standard TKA or unisex knee prosthesis was design for female and male.
Primary Outcome Measure Information:
Title
anterior knee pain
Description
Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)
Time Frame
4 years
Title
patellar tracking
Description
patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking
Time Frame
4 years
Secondary Outcome Measure Information:
Title
clinical outcome score
Description
knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)
Time Frame
4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aymptomatic knee OA with
varus deformity < 30 degrees
range of motion > 90 degrees
flexion contracture < 20 degrees
recurvatum < 20 degrees
Exclusion Criteria:
gout
postraumatic arthritis
osteonecrosis of knee
inflammatory joint disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonchana Pongcharoen, MD
Organizational Affiliation
faculty of medicine, Thammasat university
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
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