This trial is active, not recruiting.

Conditions osteoarthritis, knee, arthroplasty, replacement, knee
Treatments patient specific instrumentation (mri), patient specific instrumentation (ct)
Sponsor Kyung Hee University Gangdong Hospital
Start date February 2011
End date September 2012
Trial size 80 participants
Trial identifier NCT02500160, KHNMC 2011-058


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
MRI based patient-specific instrumentation
patient specific instrumentation (mri)
(Active Comparator)
CT based patient-specific instrumentation
patient specific instrumentation (ct)

Primary Outcomes

The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.
time frame: intraoperative time

Secondary Outcomes

radiographic assessment
time frame: postoperative 6 weeks

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Principal investigator Kang-Il Kim, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Kyung Hee University Gangdong Hospital.