3D Printing Guides in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Device: 3D-Printed Patient-Specific Intramedullary Guide

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Ⅳ;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PSI group; 3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group.	Device: 3D-Printed Patient-Specific Intramedullary Guide; The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: Rui He, M.D., Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 3DKneeGuide

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No