Lower Limb Deformity
Conditions
Interventions
Traditional surgery group:Not using 3D-printed osteotomy guides
Digital orthopedic group:Use 3D-printed osteotomy guide plates
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 80 years old; 2. There is a clear lower limb deformity, including coronal and/or sagittal and/or rotational deformity, with a deformity angle of >= 5°; 3. The doctor has diagnosed clinical symptoms that are causally related to the above lower limb deformity, including pain, joint instability, and limping; 4. And/or the deformity causes significant functional limitation; 5. And/or the patient has a strong aesthetic demand and the degree of deformity meets the above imaging standards; 6. The joint cartilage condition is relatively good, the bone development is mature, and the patient's overall health condition can tolerate elective orthopedic surgery; 7. The patient and their family fully understand the benefits and risks of this trial, can accept the surgical plan and sign the informed consent form, and can ensure participation in the entire research process and adherence to follow-up >= 12 months after surgery.
Exclusion criteria
Exclusion criteria: 1. Patients with active infections, severe vascular and nerve injuries, or those with an American Society of Anesthesiologists' Classification (ASA) score of IV or V for surgery are excluded; 2. Patients with severe systemic diseases, such as malignant tumors, severe metabolic disorders (such as uncontrolled diabetes), severe hematological diseases (such as hemolytic anemia), etc.; 3. Patients with other diseases that may affect the evaluation of therapeutic efficacy; 4. Psychiatric patients, or those with poor compliance and unwillingness to cooperate with treatment; 5. Patients with a known history of alcohol addiction or drug abuse; 6. Nursing/maternity women, women of childbearing age, or male patients whose partners do not agree to take effective contraceptive measures during the study period; 7. Patients who participated in and used other drug/medical device clinical trials within 3 months before enrollment; 8. Other patients judged by the researcher to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The deformed angle 180 days after surgical treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging assessment;Pain assessment;Function evaluation;Quality of Life Evaluation;Satisfaction evaluation;Complications; | — |
Countries
China
Contacts
Public ContactZhang Hui
West China Hospital of Sichuan University
Outcome results
None listed