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OpenTrials
Completed

NCT Number: NCT05045651

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

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

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Key information

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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 outcomes

  1. anterior knee pain

    Time frame: 4 years

    Visual analog scale for pain ( 0= no pain to 10= maximum pain), incidence for anterior knee pain (percent)

  2. patellar tracking

    Time frame: 4 years

    patellar tilt > 5 degrees and/or patellar shift> 5 mm= patellar maltracking

Secondary outcomes

  1. clinical outcome score

    Time frame: 4 years

    knee society score (0-20= poor outcomes, 21-40=fair outcomes, 41-60= good outcomes, 61-80= very good outcomes, 81-100= excellent outcome)

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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