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Efficacy and safety of knee joint surgery navigation system in total knee arthroplasty

Efficacy and safety of knee joint surgery navigation system in total knee arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047691
Enrollment
Unknown
Registered
2021-06-22
Start date
2020-01-01
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

Knee osteoarthritis

Interventions

Experimental group:Application of navigation system in total knee arthroplasty
control group:Traditional total knee arthroplasty

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Patients who need primary or unilateral total knee arthroplasty; 3. The subject / guardian can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. The contraindications of TKA were as follows (1) Patients with lower limb paralysis or neuropathic joint disease (Charcot joint); (2) Patients with neuromuscular dysfunction of lower limbs (e.g. sequelae of poliomyelitis, myasthenia, etc.) may lead to postoperative knee instability, abnormal gait or difficulty in recovery; (3) Severe systemic disease (severe diabetes, serious heart disease, severe liver and kidney dysfunction, active tuberculosis infection, hemorrhagic disease); (4) Patients with active infection around knee joint or all over the body. 2. Deep venous thrombosis of the affected limb; 3. The affected limb has a history of knee joint surgery, trauma or fracture, which affects the evaluation and operation safety of the project; 4. The subjects were immunosuppressed and suffered from autoimmune diseases or immunosuppressive disorders. For example, the patient is receiving immunosuppressive therapy (high-dose cortisol, cytotoxic drugs, anti lymphocyte serum, or high-dose radiation) or has acquired immunodeficiency syndrome; 5. Pregnant or lactating women; 6. The subjects have participated in clinical studies of other drugs, biological agents or devices in the last three months; 7. Patients with known excessive drinking or drug abuse; 8. The researcher thinks that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Correction rate of lower limb alignment after operation;

Secondary

MeasureTime frame
Hospital for special surgery score;knee society score;The Western Ontario and McMaster Universities Score;Brief Health Status Scale;

Countries

China

Contacts

Public ContactLin Jin

Peking Union Medical College Hospital

linjinpumc@163.com+86 13601157900

Outcome results

None listed

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