Hip and knee diseases
Conditions
Interventions
Test Group:Digital Orthopaedic Technology Line Arthroplasty
Conrol group:Joint replacement with traditional instruments
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 21-80 years; 2. Able to perform surgical procedures and able to cooperate in completing follow-up visits, with good compliance; 3. Need for primary unilateral hip/knee replacement; 4. No vascular or neurological injury; 5. Voluntarily participate in this trial and sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone replacement surgery of the major joints of the ipsilateral lower extremities (hip and knee joints); 2. Clinical investigators who have participated in other research drugs or devices in the past 3 months; 3. Knee fixed flexion contractures or valgus deformities > 15°; 4. Hip/knee tumors, severe hip deformities (e.g., Crope III), hip fractures; 5. Presence of ankylosing deformities of the hip or ankle; 6. Known or suspected allergies to polyethylene, titanium, cobalt, chromium or ferrous elemental materials; 7. The subject was immunosuppressed, suffering from an autoimmune disease or immunosuppressive disorder; 8. The subject is unable to support and/or fix the prosthesis due to a disease (e.g., tumor, severe osteoporosis, or metabolic bone disease, etc.); 9. Failure to understand the requirements for participation in the study, or inability to complete the study follow-up program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routin;erythrocyte sedimentation rate;C-reaction protein;Pre-operative full-length of both lower limbs;Post-operative full-length of both lower limbs;Prosthesis position;Surgery time;Intraoperative osteotomy thickness;Complications;Functional score;satisfaction;Lower limb alignment; | — |
Countries
China
Contacts
Public ContactHuang Wei
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed