Osteoarthritis of KneeNCT01449474
Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
A study testing Patient matched instruments and Jig based instruments in people with Osteoarthritis of Knee, run by Mahidol University.
Trial summary
Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Patient matched instruments and Jig based instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2011
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
Who cannot join
- Previous complex surgery of the affected knee
- Metalic implant in the affected lower limb
- Patients who unable or contraindicated to perform MRI
- Extra-articular deformities of the affected lower limb
- Extensive bone loss of distal femur or/and proximal tibia
- More than 30 degrees of knee flexion contracture
- Unable to perform TKA within 12 weeks after MRI
About this study
Official title: Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty
Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Patient matched instruments, Jig based instruments
- 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 matched instrumentsDevice
Also called The Zimmer Patient Specific Instruments System
The patients undergo TKA with using patient matched instruments
Jig based instrumentsDevice
Also called Zimmer Nexgen LPS MIS system
The patients undergo TKA with using jig based instruments
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patient matched instruments Receives: Device: Patient matched instruments |
| Group 2 | Experimental | Jig based instruments Receives: Device: Jig based instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The alignment of mechanical axis after TKA
Measured: Within 1 month after operation
Secondary outcomes (1)
The alignment of femoral and tibial components after TKA
Measured: Within 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keerati Charoencholvanich, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449474
- Sponsor's protocol ID
- Si050/2554(EC2)
- Status last verified
- Feb 2013
- First submitted
- 6 Oct 2011
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. 2013 Mar;95-B(3):354-9. doi: 10.1302/0301-620X.95B3.29903.
PubMed 23450020
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01449474
- Acronym / sponsor ID
- Si050/2554(EC2)
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Oct 2011 (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.
Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments 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 |
|---|---|---|
| Group 1 | Experimental | Device: Patient matched instrumentsPatient matched instruments |
| Group 2 | Experimental | Device: Jig based instrumentsJig based instruments |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
Key exclusion criteria (7 listed)
- Previous complex surgery of the affected knee
- Metalic implant in the affected lower limb
- Patients who unable or contraindicated to perform MRI
- Extra-articular deformities of the affected lower limb
- Extensive bone loss of distal femur or/and proximal tibia
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 matched instrumentsAlso: The Zimmer Patient Specific Instruments SystemThe patients undergo TKA with using patient matched instruments | Device | Group 1 |
| Jig based instrumentsAlso: Zimmer Nexgen LPS MIS systemThe patients undergo TKA with using jig based instruments | Device | Group 2 |
Primary outcome
The alignment of mechanical axis after TKA
Time frame: Within 1 month after operation
1 secondary outcome
The alignment of femoral and tibial components after TKA
Time frame: Within 1 month after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Derived from this study: PubMed 23450020Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. 2013 Mar;95-B(3):354-9. doi: 10.1302/0301-620X.95B3.29903.
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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.
Keerati Charoencholvanich, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Patient matched instruments and Jig based instruments in people with Osteoarthritis of Knee, run by Mahidol University.
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 7 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: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 alignment of mechanical axis after TKA (time frame: Within 1 month after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01449474, which also lists 1 linked publication.
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 22 Feb 2013; AzTrials last refreshed its copy on 2 Nov 2026.