Osteoarthritis
Conditions
Interventions
3D Group:According to morphology and sites of the bone loss, we design and print the personalized augments. And we also design and print the personalized specific instrument according to the preoperat
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects will be enrolled in this study only when they meet all of the following criteria: a) Age 18-80 years and gender; b) Meets the surgical indications for artificial total knee arthroplasty based on the clinical judgement of the study physician; c) Preoperative imaging that meets the needs of the study; d) Understand the purpose of the trial, comply with the protocol, participate voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects cannot be selected for entry into the clinical study when any of the following conditions exist: a) Presence of surgical contraindications to artificial total knee arthroplasty; b) Women who are pregnant or breastfeeding; c) Subjects who were enrolled in this clinical trial within 3 months prior to enrolment or who are currently participating in another clinical trial; d) Other conditions that, in the judgement of the investigator, make enrolment in this study unsuitable; e) Patients who are allergic to metal implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Knee Society Radiographic score;Consistency of postoperative lower extremity alignment with preoperative plan; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consistency between the amount of intraoperative osteotomy and the actual amount of intraoperative osteotomy;Intraoperative matching of 3D printed materials;Perioperative complications;Blood loss;Surgery time;Knee Injury and Osteoarthritis Outcome Score (KOOS);Visual Analogue Scale (VAS);Forgotten Joint Score (FJS);Range of motion (ROM);European Quality of Life Five Dimension Scale (EQ-5D); | — |
Countries
China
Contacts
Public ContactWenwei Qian
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed