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Multi-center, randomized, parallel controlled clinical trial of trabecular knee prosthesis system

Multi-center, randomized, parallel controlled clinical trial of trabecular knee prosthesis system

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042098
Enrollment
Unknown
Registered
2021-01-13
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Knee osteoarthritis

Interventions

control group:The control group was used for operation
experimental group:The experimental group products were used for operation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient's bones are mature; 2. The researchers determined that the patient had indications for total knee replacement surgery,Such as osteoarthritis; 3. Patients who received total knee arthroplasty for the first time and only underwent unilateral arthroplasty; 4. The patient entered the trial voluntarily and was able to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of allergies to the implanted materials or previous severe allergic reactions; 2. Female patients with a pregnancy plan within one year; 3. Female patients of childbearing age (18~60 years old, except for menopausal women) who have a positive urine pregnancy test; 4. Patients who have participated in clinical studies of other drugs and devices before being selected and have reached the study endpoint for less than 3 months; 5. Researchers believe that it is not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Joint function evaluation;

Countries

China

Contacts

Public ContactZhou Zongke

West China Hospital of Sichuan University

zongke@126.com+86 18980601028

Outcome results

None listed

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