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A clinical trial evaluating the effectiveness and safety of robotic-assisted surgery system for unicompartmental knee arthroplasty

A clinical trial evaluating the effectiveness and safety of robotic-assisted surgery system for unicompartmental knee arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077343
Enrollment
Unknown
Registered
2023-11-06
Start date
2023-11-07
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Any diseases requiring primary unicompartmental knee arthroplasty

Interventions

Control Group:Conventional unicompartmental knee arthroplasty
Experimental Group:Robot-assisted unicompartmental knee 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. Patients with indications for unicompartmental knee arthroplasty. 2. Aged 18-80 years, no gender limit, bone devoloped. 3. Body mass index (BMI) 90° 5. Patients without arthroplasty on ipsilateral joints (hip, knee or ankle). 6. Patients with the ligaments of the knee in good condition. 7. Patients without systemic infection or local infection in the operative side. 8. Patients who voluntarily participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patiens with muti-compartmental arthritis (eg: rheumatoid arthritis or hemophiliac arthritis); or with bi-compartmental osteoarthritis. 2. Patients with severe degeneration of the patellofemoral joint, such as extensive ivory-like cartilage lesions in the patella and trochlear; patients with severe osteoporosis or bone defect which greatly affect prosthesis fixation; patients with expected unsatifactory results in lower leg alignment and joint stability after surgery; patients with hip disease and significant limitation of hip movement. 3. Patients with diseases that may jeopardize implant stability or surgical recovery (such as osteitis, neuropathic joint disease, vascular insufficiency, muscular dystrophy, or uncontrolled diabetes); patients who cannot comply with the follow-up and affect the scientific integrity of the trial 4. Patients who are immunosuppressed; or with autoimmune disease. 5. Patients with coagulation dysfunction that cannot be corrected by treatment. 6. Patiens wiht history of allergy to implant materials or surgical instruments. 7. Patients with neuromotor dysfunction which can affect skeletal muscle function (such as Parkinson's disease), or wiht mental illness and unable to cooperate or unwilling to cooperate. 8. Patients who are physically weak or cannot tolerate surgery due to other serious diseases. 9. Patients who are drug or alcohol abuser. 10. Lactating women; pregnant women; or patients who have pregnant planning during the experiment. 11. Patients who participated in others clinical studies of drugs or medical devices within 1 month before enrollment. 12. Other conditions that the investigator considers inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The clinical success rate;

Secondary

MeasureTime frame
The accurate rate of implant component position;Hip-knee-ankle angle, HKA;Oxford knee score, OKS;Vasual analogue scale pain score, VAS pain score;Knee range of motion, Knee ROM;

Countries

China

Contacts

Public ContactWang Kunzheng

Second Affiliated Hospital of Xi 'an Jiaotong University

wkzh1955@163.com+86 29 8767 9869

Outcome results

None listed

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