3D Printing Guides in Total Knee Arthroplasty

Osteoarthritis of the Knee Clinical Trial

Official title:

Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04206202
• Other study ID #: 3DKneeGuide
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.

Description:

Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;

• Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade ?;

• The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.

Exclusion Criteria:

• Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;

• Patients with traumatic arthritis and inflammatory arthritis;

• Patients with huge bone defects around the knee

• Patients who had active infection around the knee;

• Patients with knee valgus deformity;

• Patients with severe extra-articular deformity;

• Patients who had previous knee surgery;

• Patients who had periarticular soft tissue dysfunction and neuropathy;

• Patients who had poor physical condition and could not withstand the operation;

• Patients who refused to be followed.

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• 3D-Printed Patient-Specific Intramedullary Guide
The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the radiological outcomes	The radiological outcomes include the hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA) of the patients. The data were collected to evaluate the accuracy of the 3DP-designed PSI.	Postoperative 12 months
Secondary	Hospital for Special Surgery knee score (HSS)	Hospital for Special Surgery knee score (HSS) was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 6 aspects as pain, function, muscle force, deformity, stability, and the range of motion. The score standard had a maximum of 100 points (best possible outcome). A total score <60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent.	Postoperative 1,6,12 months
Secondary	American Knee Society knee score (AKS)	The AKS was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 4 aspects as pain, stability, range of motion and the function. The score standard had a maximum of 100 points (best possible outcome). A total score <60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent.	Postoperative 1,6,12 months