3D Printing Guides in Total Knee Arthroplasty

NCT04206202 | Unknown

• 1 other identifier: 3DKneeGuide
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hospital for Special Surgery knee score (HSS)

  Postoperative 1,6,12 months

• American Knee Society knee score (AKS)

  Postoperative 1,6,12 months

Study Arms (1)

PSI group

EXPERIMENTAL

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

Interventions

3D-Printed Patient-Specific Intramedullary Guide DEVICE

The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.

PSI group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rui He, M.D.

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Center for Joint Surgery

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 20, 2019
• Study Start: May 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

CN (1)