Clinical study for the effectiveness of 3D printing based patient-customized knee surgery guide in arthroplasty of the knee

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009059

Enrollment

142

Registered

2023-12-19

Start date

2024-01-31

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

None listed

Interventions

Medical Device : The test group applies a 3D printed knee arthroplasty surgical guide. Produce knee arthroplasty surgical guide based on medical images(MRI/CT) for suspected knee arthroplasty. In knee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients over the age of 55 who are scheduled for artificial knee arthroplasty surgery due to arthritis 2) Patients who fully understands and agrees in writing to the informed consent form

Exclusion criteria

Exclusion criteria: 1) Patients with inflammatory arthritis or crystal deposition arthritis 2) Patients with infection of the knee joint undergoing surgery 3) Patients who have fractured the entire lower extremity including the knee joint undergoing surgery 4) Patients with body mass index(BMI) of 40 or more 5) Patients deemed unsuitable to participate in this clinical trial at the investigator's discretion

Design outcomes

Primary

Measure	Time frame
Mechanical axis (hip-knee-ankle(HKA) angle)	—

Secondary

Measure	Time frame
Joint range of motion;Mechanical axis (femoral coronal angle(FCA), tibial coronal angle(TCA), femoral sagittal angle(femoral flexion/extension angle, FSA), tibial sagittal angle(tibial posterior slope angle, TSA), femoral rotation angle(FRA));Knee Society Score (KSS) & Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).;Information of replacement;Surgery time;Blood loss;Complications	—

Measure

Time frame

Joint range of motion;Mechanical axis (femoral coronal angle(FCA), tibial coronal angle(TCA), femoral sagittal angle(femoral flexion/extension angle, FSA), tibial sagittal angle(tibial posterior slope angle, TSA), femoral rotation angle(FRA));Knee Society Score (KSS) & Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).;Information of replacement;Surgery time;Blood loss;Complications

—

Countries

Korea, Republic of

Contacts

Public ContactCheolhee Park

KyungHee University Medical Center

rdohead@hanmail.net+82-2-958-8346

Outcome results