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A multicenter comparative prospective study on the evaluation of the safety and effectiveness of the artificial intelligence based assistive system for primary total hip arthroplasty

A multicenter comparative prospective study on the evaluation of the safety and effectiveness of the artificial intelligence based assistive system for primary total hip arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033088
Enrollment
Unknown
Registered
2020-05-20
Start date
2020-05-30
Completion date
Unknown
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of hip joints

Interventions

conventional group:using preoperative templating and conventional method toaccomplish the operation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 years; 2. The skeleton of the subjects is mature; 3. Subjects should have indications for total hip replacement; 4. The affected limb of the test side was the first time to receive total hip replacement; 5. Before the operation, the subjects were willing and able to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Neuromuscular dysfunction (e.g., paralysis, myolysis or abductor weakness) of subjects may lead to instability of hip joint or abnormal gait after operation; 2. The subjects are mentally incapable or unable to understand the requirements of participating in the study; 3. Alcoholics or drug addicts, objects of drug abuse; 4. Obese subjects with BMI > 35; 5. Patients with poor diabetes control (fasting blood glucose still >= 8.0mmol/l after drug control); 6. Patients with severe liver and kidney dysfunction; 7. Objects known to have a history of allergy to one or more implanted materials; 8. Patients with active infection in hip joint or other parts of the body; 9. Patients with serious osteoporosis, metabolic osteopathy, radiation osteopathy and tumor around hip joint; 10. Pregnant or lactating women or women planning pregnancy within 12 months; 11. Patients with general diseases (including coagulation dysfunction, serious heart disease, serious respiratory disease, other patients who can not tolerate anesthesia or surgery); those who are weak or cannot tolerate surgery due to other general diseases, with life expectancy less than 2 years; 12. The subject has participated in clinical research of other drugs, biological agents or medical devices before being selected, but failed to reach the time limit of main research end point; 13. Subjects with other diseases are limited to participate in the study and cannot follow up, which affects the scientific integrity of the study; 14. The subjects do not cooperate or are not conducive to treatment and postoperative rehabilitation exercise, and their compliance is expected to be poor; 15. The subjects had a history of hip surgery; 16. Other researchers think it is not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
radiographic data;Angle of Acetabular Cup;

Secondary

MeasureTime frame
Harris hip score;FJS-12 score;

Countries

China

Contacts

Public ContactChai Wei

Chinese PLA General Hospital

chaiwei301@163.com+86 1068182255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026