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

NCT05045651 | Completed DMC

• 1 other identifier: MTU-EC-OT-1-005/55
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteo Arthritis Knee; Knee Pain Chronic

Keywords

anterior knee pain; gender knee prosthesis; patellar tracking; unisex knee prosthesis; total knee arthroplasty; patellar resurfacing

Outcome Measures

Primary Outcomes (2)

• anterior knee pain

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

  4 years

• patellar tracking

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

  4 years

Secondary Outcomes (1)

• clinical outcome score

  4 years

Study Arms (2)

patient specific knee prosthesis

EXPERIMENTAL

TKA with Gender Solution® posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA

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

Unisex knee prosthesis

EXPERIMENTAL

TKA with posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA

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

Interventions

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.

Unisex knee prosthesis; patient specific knee prosthesis

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aymptomatic knee OA with
• varus deformity \< 30 degrees
• range of motion \> 90 degrees
• flexion contracture \< 20 degrees
• recurvatum \< 20 degrees

You may not qualify if:

• gout
• postraumatic arthritis
• osteonecrosis of knee
• inflammatory joint disease

Sponsors & Collaborators

• Thammasat University: lead

Study Officials

• Boonchana Pongcharoen, MD

  faculty of medicine, Thammasat university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 16, 2021
• Study Start: August 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share