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An exploratory study on the application of navigation system to assist knee replacement in orthopaedic surgery

An exploratory study on the application of navigation system to assist knee replacement in orthopaedic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038579
Enrollment
Unknown
Registered
2020-09-24
Start date
2020-09-30
Completion date
Unknown
Last updated
2020-11-30

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:Knee replacement surgery will be assisted by orthopedic surgical navigation system.

Sponsors

The First Hospital Affiliated To AMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with 21 years old <= actual age < 75 years old; 2. Patients who are able to perform surgery and follow-up with good compliance; 3. Patients who need unilateral knee replacement; 4. Subjects with good functional ligaments; 5. The subjects who voluntarily participate in the test and are willing to sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. Subjects whose major joints (hip and knee joints) of the same side of the lower limb have been replaced; 2. Subjects who have participated in clinical research of other investigational drugs or devices in the past 3 months; 3. Patients with fixed flexion contracture or varus greater than 15 degrees; 4. Patients with ankylosis of hip or ankle; 5. Patients who are known or suspected to be allergic to polyethylene, titanium, cobalt, chromium or ferrous materials; 6. Patients with immunosuppressive state, autoimmune disease or immunosuppressive disorder; 7. Subjects who are unable to support and / or fix the prosthesis due to diseases (such as tumor, severe osteoporosis, or metabolic osteopathy, etc.); 8. Subjects who could not understand the requirements of participating in the study or could not complete the follow-up plan of the study; 9. Other researchers think it is not suitable for this clinical study.

Design outcomes

Primary

MeasureTime frame
The occurrence of adverse events;Deviation Angle of limb alignment;the Western Ontario and McMaster Universities Osteoarthritis Index;Knee Society Score;

Countries

China

Contacts

Public ContactLiu Yang

the First Affiliated Hospital of PLA Army Medical University

jointsurgery@163.com+86 13908399739

Outcome results

None listed

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