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Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.

Primary Purpose

Osteoarthritis, Knee, Arthroplasty, Replacement, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Patient specific instrumentation (MRI)
Patient specific instrumentation (CT)
Sponsored by
Kyung Hee University Hospital at Gangdong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Of the patients who had been scheduled for TKA for the treatment of primary osteoarthritis only with varus deformity, those who had been waiting 6 weeks for TKA using an MRI-based or CT-based PSI system and had consented to the relatively new technique were enrolled in the study.

Exclusion Criteria:

  • Patients with primary osteoarthritis with valgus deformity, rheumatoid arthritis, hemophilic arthritis, posttraumatic arthritis, other inflammatory arthritis, or a history of previous high tibial osteotomy were excluded from the study.

Sites / Locations

  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patient specific instrumentation (MRI)

patient specific instrumentation (CT)

Arm Description

MRI based patient-specific instrumentation

CT based patient-specific instrumentation

Outcomes

Primary Outcome Measures

The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.
After bone resection using a patient-specific cutting jig, the actual thickness of resected bone was measured in 0.1 mm increments by the Vernier caliper (B.Braun-Aesculap, Tuttlingen, Germany) and compared with the planned resection thickness preoperatively using the PSI program.In the MRI group, the intraoperative cutting thickness was compared directly with the preoperatively planned thickness, whereas the presumed thickness of cartilage (2 mm) was added to actual thickness of resected bone from the lateral condyles in the CT group. Finally, the thickness of saw blade (1.27-mm) was added to every resected bone in all cases.

Secondary Outcome Measures

radiographic assessment
The mechanical axis (MA) of the lower extremity and the coronal and sagittal alignments of the femoral and tibial components were measured on the anterior and lateral weight-bearing radiographs of the knee and the lower extremity orthogram before the surgery and 6 weeks after the surgery. The measurements were performed using a picture-acquiring communication system (PACS, Infinitt Healthcare, Seoul, Korea), and the data were recorded to one decimal place.

Full Information

First Posted
July 13, 2015
Last Updated
July 14, 2015
Sponsor
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT02500160
Brief Title
Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong

4. Oversight

5. Study Description

Brief Summary
Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA) as a new technology for improving accuracy in restoration of the alignment and biomechanics of the lower limb. PSI in TKA refers to custom-made cutting jigs manufactured according to the patient's anatomic configuration of distal femur and proximal tibia based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans. MRI- and CT-based PSI systems are available from various manufacturers for preoperative planning. MRI offers precise visualization of articular cartilage without the risk of radiation exposure, but it is expensive and requires long scan times. In contrast, CT enables accurate identification of the contour of the femur and tibia at short scan times, but it does not provide information on the cartilage thickness and carries the risk of radiation exposure. As a result, there is a possibility of some discrepancy between the thickness of bone resection proposed by MRI- or CT-based PSI system and the actual thickness of bone cut. Although PSI has been the focus of study in many recent researches, there has been no clinical study comparing MRI-based and CT-based PSI systems in preoperative planning. Therefore the investigators questioned whether the MRI-based PSI that reflects the cartilage layer would provide more precision in TKA than the CT-based PSI. The purpose of this study was to investigate the accuracy of MRI-based PSI and CT-based PSI in predicting bone resection thickness in TKA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Arthroplasty, Replacement, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient specific instrumentation (MRI)
Arm Type
Experimental
Arm Description
MRI based patient-specific instrumentation
Arm Title
patient specific instrumentation (CT)
Arm Type
Active Comparator
Arm Description
CT based patient-specific instrumentation
Intervention Type
Device
Intervention Name(s)
Patient specific instrumentation (MRI)
Intervention Type
Device
Intervention Name(s)
Patient specific instrumentation (CT)
Primary Outcome Measure Information:
Title
The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.
Description
After bone resection using a patient-specific cutting jig, the actual thickness of resected bone was measured in 0.1 mm increments by the Vernier caliper (B.Braun-Aesculap, Tuttlingen, Germany) and compared with the planned resection thickness preoperatively using the PSI program.In the MRI group, the intraoperative cutting thickness was compared directly with the preoperatively planned thickness, whereas the presumed thickness of cartilage (2 mm) was added to actual thickness of resected bone from the lateral condyles in the CT group. Finally, the thickness of saw blade (1.27-mm) was added to every resected bone in all cases.
Time Frame
intraoperative time
Secondary Outcome Measure Information:
Title
radiographic assessment
Description
The mechanical axis (MA) of the lower extremity and the coronal and sagittal alignments of the femoral and tibial components were measured on the anterior and lateral weight-bearing radiographs of the knee and the lower extremity orthogram before the surgery and 6 weeks after the surgery. The measurements were performed using a picture-acquiring communication system (PACS, Infinitt Healthcare, Seoul, Korea), and the data were recorded to one decimal place.
Time Frame
postoperative 6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Of the patients who had been scheduled for TKA for the treatment of primary osteoarthritis only with varus deformity, those who had been waiting 6 weeks for TKA using an MRI-based or CT-based PSI system and had consented to the relatively new technique were enrolled in the study. Exclusion Criteria: Patients with primary osteoarthritis with valgus deformity, rheumatoid arthritis, hemophilic arthritis, posttraumatic arthritis, other inflammatory arthritis, or a history of previous high tibial osteotomy were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang-Il Kim, MD,PhD
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-090
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.

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