Osteoarthritis, KneeVisioNCT02002624
Patient-Specific Versus Conventional Instrumentation in TKA
A study testing PSI and Conventional instrumentation in people with Osteoarthritis, Knee, run by Cochin Hospital.
Trial summary
The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PSI and Conventional instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jul 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
- aged between 18 and 85 years
- able to understand information
- affiliated to social security.
Who cannot join
- active or suspected sepsis
- tumor around the knee
- previous partial or total knee replacement
- presence of hardware that could artifact MRI
- contraindication to MRI
- extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
- social situation that could impair follow-up.
About this study
Official title: RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA
The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.
- Conditions
- Osteoarthritis, Knee
- Being tested
- PSI, Conventional instrumentation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSIDevice
Also called Patient specific instrumentation
Conventional instrumentationDevice
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Conventional instrumentation Receives: Device: Conventional instrumentation |
| PSI | Experimental | Patient specific instrumentation Receives: Device: PSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical axis
Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the HKA (hip-knee-ankle) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.
Measured: 3 months
Secondary outcomes (1)
Components position
Also, components position in the coronal plane was measured on both the tibial and femoral sides by the femoral (F) angle between the tangent line of the distal prosthetic condyles and the mechanical axis of the femur, and by the tibial (T) angle between the tangent line of the prosthetic tibial baseplate and the mechanical axis of the tibia. In addition in the sagittal plane, tibial slope (TS) was measured by the angle between the tangent of the tibial baseplate and the posterior cortex of the tibia on a lateral view of the knee made at three-month follow-up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochin Hospital
- Responsible party
- Principal investigator, Moussa Hamadouche, Cochin Hospital
- Investigators
- Stephane Boisgard, MD, PhD, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002624
- Sponsor's protocol ID
- CCP SC 2837
- Acronym
- Visio
- Status last verified
- Dec 2013
- First submitted
- 1 Dec 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA
- ClinicalTrials.gov ID
- NCT02002624
- Acronym / sponsor ID
- Visio / CCP SC 2837
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cochin Hospital
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Dec 2013 (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.
The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Device: Conventional instrumentationConventional instrumentation |
| PSI | Experimental | Device: PSIPatient specific instrumentation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
- aged between 18 and 85 years
- able to understand information
- affiliated to social security.
Key exclusion criteria (7 listed)
- active or suspected sepsis
- tumor around the knee
- previous partial or total knee replacement
- presence of hardware that could artifact MRI
- contraindication to MRI
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 |
|---|---|---|
| PSIAlso: Patient specific instrumentation | Device | PSI |
| Conventional instrumentation | Device | Conventional |
Primary outcome
Mechanical axis
Time frame: 3 months
Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the HKA (hip-knee-ankle) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.
1 secondary outcome
Components position
Time frame: 3 months
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 6 Dec 2013.
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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.
Stephane Boisgard, MD, PhD study director
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A study testing PSI and Conventional instrumentation in people with Osteoarthritis, Knee, run by Cochin Hospital.
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 4 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 6 Dec 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?
Mechanical axis (time frame: 3 months). 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 6 Dec 2013.