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

NCT06527911 · Chinese PLA General Hospital · Updated 30 July 2024

What is being tested
Not stated
For
Arthroplasty; Replacement; Knee; Osteoarthritis; Robotic Surgical Procedures
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 100 people. The full rules are on the registry page.
Where
China
When
Starts or started 1 Sept 2024, ends 1 Sept 2026. Registered 30 July 2024.
Results
None posted yet.

In the researchers' words

As China transitions into an aging society, the proportion of the elderly population is escalating, with a corresponding rise in the number of patients with knee joint diseases. Total knee arthroplasty stands as an effective treatment for joint disorders, effectively reducing knee pain, restoring functionality, and enhancing quality of life. The objectives of total knee arthroplasty are to relieve pain, restore function, and ensure a long-lasting implant. In recent years, technological advancements have integrated robotic assistance into total knee arthroplasty (TKA), aiding surgeons in planning and executing more accurate surgical plans, significantly enhancing precision and post-operative outcomes. However, the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb, and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures, necessitating adjustments by surgeons based on their experience. Consequently, there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment. Additionally, the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue, and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA, necessitating further…
ClinicalTrials.gov, NCT06527911

Sites

  • Chinese PLA General HospitalBeijing, Beijing Municipality, China