Osteoarthritis, KneeNCT02500160
Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.
A study testing Patient specific instrumentation (MRI) and Patient specific instrumentation (CT) in people with Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- Patient specific instrumentation (MRI) and Patient specific instrumentation (CT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, 134-090
About this study
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.
- Being tested
- Patient specific instrumentation (MRI), Patient specific instrumentation (CT)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific instrumentation (MRI)Device
Patient specific instrumentation (CT)Device
| Study group | Role | What they receive |
|---|---|---|
| patient specific instrumentation (MRI) | Experimental | MRI based patient-specific instrumentation Receives: Device: Patient specific instrumentation (MRI) |
| patient specific instrumentation (CT) | Active comparator | CT based patient-specific instrumentation Receives: Device: Patient specific instrumentation (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative time
Secondary outcomes (1)
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.
Measured: postoperative 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KANG-IL KIM, Kyung Hee University Hospital at Gangdong
- Investigators
- Kang-Il Kim, MD,PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500160
- Sponsor's protocol ID
- KHNMC 2011-058
- Status last verified
- Jul 2015
- First submitted
- 13 Jul 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.
- ClinicalTrials.gov ID
- NCT02500160
- Acronym / sponsor ID
- KHNMC 2011-058
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient specific instrumentation (MRI) | Experimental | Device: Patient specific instrumentation (MRI)MRI based patient-specific instrumentation |
| patient specific instrumentation (CT) | Active comparator | Device: Patient specific instrumentation (CT)CT based patient-specific instrumentation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient specific instrumentation (MRI) | Device | patient specific instrumentation (MRI) |
| Patient specific instrumentation (CT) | Device | patient specific instrumentation (CT) |
Primary outcome
The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.
Time frame: intraoperative time
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.
1 secondary outcome
radiographic assessment
Time frame: postoperative 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kang-Il Kim, MD,PhD principal investigator
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific instrumentation (MRI) and Patient specific instrumentation (CT) in people with Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia. (time frame: intraoperative time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.