A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic TKA and Manual TKA

Launched by CHINESE PLA GENERAL HOSPITAL · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the differences in knee alignment between two surgical methods for total knee replacement: one using the Mako robotic system and the other using traditional manual techniques. As more elderly people face knee problems, this research aims to understand which method provides better alignment and outcomes after surgery. The trial will take place at the People's Liberation Army General Hospital and plans to enroll about 100 participants who are between 18 to 80 years old and have osteoarthritis.

To be part of this study, participants should have knee osteoarthritis and be undergoing either the Mako robot-assisted or manual total knee replacement surgery. They will need to agree to take specific X-rays before and after their surgery and be in good physical and mental health to cooperate with the study. Throughout the trial, participants can expect close monitoring and follow-up to assess their recovery and the effectiveness of the surgery. This research is important because it will help improve surgical techniques and patient outcomes in knee replacements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The age ranged from 18 to 80 years old;
• • 2. OA patients who underwent Mako robot assisted TKA and manual TKA (Stryker Triathlon prosthesis) in the Department of joint surgery of the PLA General Hospital from September 2024 to September 2026;
• • 3. All patients were required to take full-length anteroposterior and lateral radiographs of lower limbs, anteroposterior and lateral radiographs of both knees, and lower limb sagittal EOS before and after surgery;
• • 4. Physical and mental health, able to participate in and cooperate with the test;
• • 5. Patients are willing to participate in the study and sign written informed consent.
• Exclusion Criteria:
• • 1. People unable to conduct EOS inspection;
• • 2. Combined with knee meniscus injury, anterior cruciate ligament injury and other diseases that may affect the sagittal force line of the knee joint
• • 3. Combined with other diseases that may affect the study
• • 4. Patients refused to use their imaging data and knee score for this study.