Knee osteoarthritis
Conditions
Interventions
Control Group:Control group: The total knee prosthesis used, including femur parts, tibial pads, and tibial parts (tibial brackets), were all manufactured by Beijing Lidakang Technology Co., LTD. (Nat
Experimental group:Experimental group: Additive manufacturing titanium alloy knee prosthesis, made by Beijing Lidakang Technology Co., LTD., composed of femur parts, tibial pads and tibial parts (tibi
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged 50-80 years old, gender unlimited, young patients should have urgent need for surgery; 2) The patient has mature bones; 3) The subjects had indications for total knee replacement, such as non-inflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or avascular necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional malformations; 4) The affected limb of the subject received total knee replacement for the first time; 5) Before surgery, the subject or guardian is willing and able to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) The patient's neuromuscular insufficiency (e.g., paralysis, myolysis, or myasthenia) may lead to postoperative knee instability or abnormal gait; 2) The patient is mentally incapable or unable to understand the requirements for participating in the study; 3) alcoholics or drug addicts, drug abusers; 4) Poor compliance is expected; 5) Obesity: BMI > 35; 6) The patient is known to have a history of allergy to one or more implanted materials; 7) There are active infection lesions in the knee joint or other parts of the body; 8) Serious osteoporosis, metabolic bone disease, radiation bone disease, and tumor around the knee joint; 9) Pregnant or lactating women; 10) Those who are physically weak or cannot tolerate surgery due to other systemic diseases; 11) Operative lower extremity venous thrombosis; 12) The subject's co-existing medical conditions limit his/her participation in the study, prevent him/her from complying with follow-up or affect the scientific integrity of the study; 13) Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not meet the primary study endpoint time limit; 14) Participants with other conditions that the investigator considers inappropriate for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score(KSS);Lower extremity venous color ultrasound; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale(VAS);Hospital for Special Surgery Score(HSS);Plain X-ray film parameters - Postoperative imaging implantation was successful;CT image parameter; | — |
Countries
China
Contacts
Public ContactJun Xiao
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed