Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA

Osteo Arthritis Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045651
• Other study ID #: MTU-EC-OT-1-005/55
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2021
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unisex knee prosthesis and patient specific knee prosthesis has the same anterior knee pain and patellar tracking

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Pain Chronic
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anterior knee pain	Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)	4 years
Primary	patellar tracking	patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking	4 years
Secondary	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)	4 years