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A multicenter comparative prospective study on the artificial intelligence based assistive system and the MAKO robotic system for primary total hip arthroplasty

A multicenter comparative prospective study on the artificial intelligence based assistive system and the MAKO robotic system for primary total hip arthroplasty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034075
Enrollment
Unknown
Registered
2020-06-22
Start date
2020-07-30
Completion date
Unknown
Last updated
2020-06-29

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

MAKO robotic group:using mannual preoperative plan for MAKO surgery and MAKO robot to accompish the operation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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. Patients who are willing and able to sign informed consent before operation.

Exclusion criteria

Exclusion criteria: 1. Patients with neuromuscular dysfunction (such as paralysis, myolysis or abductor weakness) may lead to instability of hip joint or abnormal gait; 2. Mentally incapacitated or unable to understand the requirements of participating in the study; 3. Alcoholics or drug users, drug abuse patients; 4. Obese patients 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. Patients who have known 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. Patients who have participated in clinical studies of other drugs, biological agents or medical devices before inclusion but failed to reach the main end-point time limit of the study; 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. Patients who do not cooperate or are not conducive to treatment and postoperative rehabilitation exercise and are expected to have poor compliance; 15. Patients with previous history of hip surgery; 16. Other circumstances that the researcher thinks are not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
the anteversion angle of acetabular ;radiographic data;

Countries

China

Contacts

Public ContactChai Wei

Chinese PLA General Hospital

chaiwei301@163.com+86 13601372998

Outcome results

None listed

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