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Is Soft Tissue Deformation Under Coronal Stress After Robot-Assisted Total Knee Arthroplasty Superior to Conventional Total Knee Arthroplasty: A Prospective, Multicenter, Randomized Controlled Trial

Is Soft Tissue Deformation Under Coronal Stress After Robot-Assisted Total Knee Arthroplasty Superior to Conventional Total Knee Arthroplasty: A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096336
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

The patient requires total knee arthroplasty due to severe knee pain, joint deformity, and limited joint mobility.

Interventions

Control group:Using conventional knee replacement surgery.
Experimental group:Using robot-assisted knee replacement surgery.

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.18< = age< = 85 years old, gender is not limited; 2. Unilateral primary total knee arthroplasty to be performed; 3. The subject or his/her guardian is informed of this study and agrees to all the terms of this trial, signs the informed consent form approved by the ethics committee, and agrees to participate in this trial.

Exclusion criteria

Exclusion criteria: 1. Joint lesions in the lower limbs on the side to be operated with obvious bone defects or significant limitation of joint movement; 2. Uncontrolled acute and chronic infections at the proposed surgical site or throughout the body; 3. Body mass index (BMI) >35kg/m^2; 4. Suffering from severe osteoporosis; 5. Suffering from mental illness, lower limb neuromuscular disease and other diseases that affect the normal function and rehabilitation after surgery; 6. Patients with severe cardiopulmonary insufficiency, liver and kidney insufficiency, etc., who cannot tolerate surgery; 7. Those who are known to be allergic to implanted prosthetic materials; 8. There is a bone tumor at the proposed surgical site; 9. The subject is a pregnant or lactating female; 10. Participated in or is participating in clinical trials of other drugs, biological agents or devices within 1 month before the proposed enrollment; 11. Other circumstances judged by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The deformation under a 100N valgus stress;

Secondary

MeasureTime frame
HKA angle;Knee joint ROM, KSS score, SF-36 score, WOMAC score, pain score;The deformation under a 100N varus stress;

Countries

China

Contacts

Public ContactTian Run

The Second Affiliated Hospital of Xi'an Jiaotong University

ortianrun@163.com+86 29 87679361

Outcome results

None listed

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