Status:
COMPLETED
Early Radiographic and Clinical Outcomes of Robotic-Arm-Assisted Versus Conventional TKA
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Qianfoshan Hospital
Chifeng Municipal Hospital
Conditions:
Total Knee Arthroplasty
Robotic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Purpose: A robotic system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) st...
Detailed Description
2\. Materials and methods 2.1 Study design Our study was a prospective, multicenter and randomized controlled trial that was approved by the Institutional Review Board of Peking University Third Hospi...
Eligibility Criteria
Inclusion
- older than 18 years old and younger than 80 years old with knee osteoarthritis undergoing primary and unilateral TKA
- after receiving both an oral and a written explanation of the study protocol, they provided written informed consent that they were willing to complete all of the assessments and potential interventions
Exclusion
- Allergic to metal implants
- Any active systemic and local infection
- Paralysis of muscles around the knee joint or neuropathic arthropathy
- The knee joint has been fused for a long time without pain and deformity
- Patients with severe systemic diseases (severe diabetes, severe osteoporosis, severe muscle loss, etc.), or those who cannot tolerate surgery through systemic evaluation
- Women who are pregnant or breastfeeding, or who expect to give birth during the clinical period
- Patients who are also participating in other clinical studies
- In any case, if the investigator believes that the patient is not suitable for this treatment (the patient's expectations are unrealistic or the patient has significant emotional problems)
- There are other factors that affect the efficacy of observation in this study
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05987839
Start Date
November 1 2022
End Date
June 30 2023
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191