Skip to content

A randomized controlled trial for the effect of 3D-printed PSI instrument based on AI preoperative planning system in TKA

A randomized controlled trial for the effect of 3D-printed PSI instrument based on AI preoperative planning system in TKA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067331
Enrollment
Unknown
Registered
2023-01-04
Start date
2023-01-04
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

osteoarthritis

Interventions

group 1:Perform TKA using 3D-printed PSI instrument based on AI preoperative planning system.
group 2:Perform TKA using conventional instrument and technique

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with unilateral total knee arthroplasty for the first time; 2. Age >= 20 years old, < 80 years old, gender is not limited; 3. Patients who used aspirin before surgery should stop taking aspirin for more than 1 week; 4. The subjects gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Preoperative evaluation requires the use of extension rod prosthesis, revision prosthesis or restrictive prosthesis; 2. Revision knee surgery; 3. Combined with other serious organ diseases such as heart, brain, lung, kidney, blood; 4. Receive major orthopedic surgery within three weeks before surgery; 5. I refuse to participate in the research.

Design outcomes

Primary

MeasureTime frame
hip knee ankle angle;

Secondary

MeasureTime frame
American Knee Society (KSS) score;Range of motion of knee;

Countries

China

Contacts

Public ContactBin Feng

Peking Union Medical College Hospital

pumcfeng@163.com+86 138 1048 7811

Outcome results

None listed

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