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A prospective, multicentered, randomized controlled clinical trial evaluating the safety and effectiveness of the robotic surgery system for total hip arthroplasty

A prospective, multicentered, randomized controlled clinical trial evaluating the safety and effectiveness of the robotic surgery system for total hip arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060115
Enrollment
Unknown
Registered
2022-05-19
Start date
2020-12-29
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Hip disease

Interventions

Experimental group:robot-assisted total hip arthroplasty

Sponsors

The Second Affiliated Hospital of Xi 'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, no gender limit. 2. The subjects had indications of total hip replacement surgery (primary or secondary hip osteoarthritis, avascular necrosis of femoral head, femoral neck fracture, etc.). 3. The subject received total hip replacement for the first time. 4. The subject or his legal agent is informed of the nature of the study and agrees to participate in all terms of the study, and agrees to participate in the study by signing the informed consent approved by the Ethics Committee.

Exclusion criteria

Exclusion criteria: 1. BMI > 35; 2. Postoperative hip instability or gait abnormalities (e.g. paralysis, myolysis, or abductor weakness) due to neuromuscular dysfunction; 3. Active infection of the hip joint or other parts of the body; 4. The patient is known to have severe osteoporosis, metabolic bone disease, and radioactive bone disease around the hip joint; 5. The patient is known to have a history of allergy to one or more implanted materials; 6. Coagulation dysfunction, which cannot be corrected or has bleeding tendency; 7. Pregnant or planning to become pregnant during the study period; 8. Participated in other drug or medical device clinical trials within 30 days prior to screening; 9. The investigator judged that the patient had poor compliance and could not complete the study as required; 10. Other circumstances considered by the investigator to be inappropriate for participation in the trial.

Design outcomes

Primary

MeasureTime frame
The accuracy of acetabular cup placement;

Secondary

MeasureTime frame
The deviation of acetabular cup anteversion;The deviation of acetabular cup inclination;Lower limb length difference;Acetabular cup size deviation;Combined offset;Operation time;Harris Hip Joint Function Scale;

Countries

China

Contacts

Public ContactWang Kunzheng
wkzh1955@163.com+86 29 87679869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 24, 2026