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

NCT02500160 | Unknown

• 1 other identifier: KHNMC 2011-058
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  intraoperative time

Secondary Outcomes (1)

• radiographic assessment

  postoperative 6 weeks

Study Arms (2)

patient specific instrumentation (MRI)

EXPERIMENTAL

MRI based patient-specific instrumentation

Device: Patient specific instrumentation (MRI)

patient specific instrumentation (CT)

ACTIVE COMPARATOR

CT based patient-specific instrumentation

Device: Patient specific instrumentation (CT)

Interventions

Patient specific instrumentation (MRI) DEVICE

patient specific instrumentation (MRI)

Patient specific instrumentation (CT) DEVICE

patient specific instrumentation (CT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 134-090, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Kang-Il Kim, MD,PhD

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor & chairman, department of orthopaedic surgery

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 16, 2015
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

KR (1)