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Search / Trial NCT06835621

Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.

Launched by THAMMASAT UNIVERSITY · Feb 14, 2025

Trial Information

Current as of September 10, 2025

Not yet recruiting

Keywords

Osteoarthritis (Oa) Of The Knee Oa Knee Mako Kinematic Alignment Mechanical Alignment Restricted Kinematic Alignment Inversed Kinematic Alignment Inversed Restricted Kinematic Alignment Robotic Assist Total Knee Arthroplasty Adjusted Mechanical Alignment

ClinConnect Summary

This clinical trial is looking to find out which surgical technique helps patients recover better after having a robotic-assisted total knee replacement due to osteoarthritis (OA). Specifically, it compares two methods: the restricted inverse kinematic alignment (restricted iKA) and the adjusted mechanical alignment (aMA). The researchers will mainly measure recovery by how far participants can walk in two minutes, but they will also check for pain levels, satisfaction, and how well the knee functions after surgery.

To participate in this trial, individuals need to be between 50 and 80 years old and diagnosed with OA of the knee, which requires surgery. They should also be generally healthy, without serious other health issues. If someone joins the trial, they will be randomly assigned to one of the two surgical methods and will return for follow-up visits to track their recovery progress. This trial aims to help find the best approach for quicker and better recovery after knee surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 50 - 80 years old
  • Diagnosed with primary OA knee and indicated for unilateral total knee arthroplasty with MAKO robotic-assisted knee replacement system
  • ASA classification I-II
  • Exclusion Criteria:
  • Valgus deformity
  • KL grading \> 3 on contralateral knee
  • Unable or difficulty for walking due to comorbidities
  • BMI \> 40 kg/m2
  • Previous knee surgery
  • Infection around the knee

About Thammasat University

Thammasat University, a leading academic institution in Thailand, is dedicated to advancing medical research and education through its various faculties and research centers. With a commitment to fostering innovative healthcare solutions, the university sponsors clinical trials aimed at enhancing patient outcomes and addressing pressing health challenges. Leveraging a multidisciplinary approach, Thammasat University collaborates with healthcare professionals and researchers to ensure rigorous scientific methodologies and ethical standards are upheld in all its clinical research endeavors. Through these initiatives, the university seeks to contribute significantly to the global body of medical knowledge and improve public health.

Locations

Klongluang, Pathum Thani, Thailand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported