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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065786
Enrollment
Unknown
Registered
2022-11-15
Start date
2021-07-08
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Any diseases requiring primary total knee arthroplasty

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years, no limitation on gender; 2. Patients had symptoms or diseases requiring primary TKA; 3. Patient or guardian is informed of this study, agrees to all terms of this study, and agrees to participate in this study by signing an informed consent form approved by the Ethics Committee.

Exclusion criteria

Exclusion criteria: 1. Knee lesions with obvious bone defect or significant limitation of joint movement in the lower extremity of the intended surgical side; 2. Acute and chronic infection of the intended surgical site or the whole body was not controlled; 3. Body mass index (BMI) > 35kg/m^2; 4. Severe osteoporosis; 5. Patients with mental diseases, neuromuscular diseases of lower extremity and other diseases affecting normal function recovery after surgery; 6. Patients with severe cardiopulmonary insufficiency or liver and kidney insufficiency who cannot tolerate surgery; 7. Known allergy to implant materials; 8. Bone tumor at the proposed surgical site; 9. Patients are pregnant or lactating; 10. Participated in or is participating in clinical trials for other drugs, biologics or devices within 1 month prior to the trial; 11. Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
The prevalence of outliers of limb alignment;

Secondary

MeasureTime frame
Hip-knee-ankle angle, HKA;Coronal femoral component angle;Coronal tibial component angle;Sagittal femoral component angle;Sagittal tibial component angle;Range of motion, ROM;Knee society score, KSS;The 36-item short from health survey, SF-36;Visual analogue scale, VAS;

Countries

China

Contacts

Public ContactWang Kunzheng

The Second Affiliated Hospital of Xi 'an Jiaotong University

wkzh1955@163.com+86 29 87679869

Outcome results

None listed

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