Back to results3D Printing Guides in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis of the Knee
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D-Printed Patient-Specific Intramedullary Guide
Sponsored by
About this trial
This is an interventional device feasibility trial for Osteoarthritis of the Knee
Eligibility Criteria
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.
Sites / Locations
- Southwest Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSI group
Arm Description
3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04206202
First Posted
December 15, 2019
Last Updated
December 17, 2019
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04206202
Brief Title
3D Printing Guides in Total Knee Arthroplasty
Official Title
Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSI group
Arm Type
Experimental
Arm Description
3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group.
Intervention Type
Device
Intervention Name(s)
3D-Printed Patient-Specific Intramedullary Guide
Intervention Description
The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.
Primary Outcome Measure Information:
Title
Change of the radiological outcomes
Description
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.
Time Frame
Postoperative 12 months
Secondary Outcome Measure Information:
Title
Hospital for Special Surgery knee score (HSS)
Description
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.
Time Frame
Postoperative 1,6,12 months
Title
American Knee Society knee score (AKS)
Description
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.
Time Frame
Postoperative 1,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui He, M.D.
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
Country
China
12. IPD Sharing Statement
Learn more about this trial
3D Printing Guides in Total Knee Arthroplasty
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