Knee OsteoarthritisPhase 4NCT02128464
Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide
A Phase 4 study testing Patient specific cutting guides and Standard knee cutting guides in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
Trial summary
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Patient specific cutting guides and Standard knee cutting guides
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to May 2014
- Phase
- Phase 4
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-90
- Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
- Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- Correction of varus or valgus.
- Willing to participate and return for follow-up study visits.
Who cannot join
- Vascular insufficiency
- Previous deep vein thrombosis and pulmonary embolism
- Previous osteotomy
- Previous patella fracture or surgery
- Previous healed tibia or femur fractures
- Previous joint replacement surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital.
Pathum Thani, Changwat Pathum Thani, 12120
About this study
Official title: Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.
Read the detailed description
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.
- Conditions
- Knee Osteoarthritis
- Being tested
- Patient specific cutting guides, Standard knee cutting guides
- Keywords
- Knee Osteoarthritis, Total Knee Arthroplasty, Customized Cutting Block, Conventional Intramedullary Cutting Guide
- 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 cutting guidesProcedure or surgery
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Standard knee cutting guidesProcedure or surgery
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
| Study group | Role | What they receive |
|---|---|---|
| Standard knee cutting guides | Active comparator | Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod. Receives: Procedure: Standard knee cutting guides |
| Patient specific cutting guides | Active comparator | Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone. Receives: Procedure: Patient specific cutting guides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation
Measured: 3 Months Post-operative
Secondary outcomes (8)
Intraoperative Bleeding
Measured: Intra-operative
Operative time
Measured: During the procedure
Blood volume in suction drain
Measured: Post-operative Day 2
Hemoglobin level
Measured: Post-operative day1, 2, 3
WOMAC score
Measured: 6 weeks
WOMAC score
Measured: 3 Months
WOMAC score
Measured: 6 Months
WOMAC score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phonthakorn Panichkul, Thammasat University
- Investigators
- Phonthakorn Panichkul, MD, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128464
- Sponsor's protocol ID
- OrthoTu-02
- Other IDs
- OrthoTu-02
- Status last verified
- Jul 2016
- First submitted
- 25 Nov 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02128464
- Acronym / sponsor ID
- OrthoTu-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Total Knee Arthroplasty, Customized Cutting Block, Conventional Intramedullary Cutting Guide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 May 2014 (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.
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.
Detailed description
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard knee cutting guides | Active comparator | Procedure: Standard knee cutting guidesStandard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod. |
| Patient specific cutting guides | Active comparator | Procedure: Patient specific cutting guidesPatient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60-90
- Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
- Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
- Correction of varus or valgus.
- Willing to participate and return for follow-up study visits.
Key exclusion criteria (6 listed)
- Vascular insufficiency
- Previous deep vein thrombosis and pulmonary embolism
- Previous osteotomy
- Previous patella fracture or surgery
- Previous healed tibia or femur fractures
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 cutting guidesPatient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone. | Procedure or surgery | Patient specific cutting guides |
| Standard knee cutting guidesStandard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod. | Procedure or surgery | Standard knee cutting guides |
Primary outcome
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
Time frame: 3 Months Post-operative
Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation
8 secondary outcomes
Intraoperative Bleeding
Time frame: Intra-operative
Operative time
Time frame: During the procedure
Blood volume in suction drain
Time frame: Post-operative Day 2
Hemoglobin level
Time frame: Post-operative day1, 2, 3
WOMAC score
Time frame: 6 weeks
WOMAC score
Time frame: 3 Months
WOMAC score
Time frame: 6 Months
WOMAC score
Time frame: 1 year
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 29 Jul 2016.
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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.
Phonthakorn Panichkul, MD principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patient specific cutting guides and Standard knee cutting guides in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
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 5 inclusion and 6 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 29 Jul 2016. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films (time frame: 3 Months Post-operative). 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 29 Jul 2016.