Osteoarthritis,KneeMyKneeNCT02966613
Fully Disposable Patient-Specific Instrumentation
A study testing GMK Medacta Total Knee arthroplasty in people with Osteoarthritis,Knee, run by Cochin Hospital.
Trial summary
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific 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?
- GMK Medacta Total Knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Sep 2016
- 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 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
- extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
- social situation that could impair follow-up
About this study
Official title: Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.
Read the detailed description
The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).
- Conditions
- Osteoarthritis,Knee
- Being tested
- GMK Medacta Total Knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMK Medacta Total Knee arthroplastyDevice
Total Knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| CI | Active comparator | TKA using conventional instrumentation (CI) Receives: Device: GMK Medacta Total Knee arthroplasty |
| PSCG | Experimental | TKA performed using Patient specific cutting guides (PSCG) Receives: Device: GMK Medacta Total Knee arthroplasty |
| PSCG-D | Experimental | TKA performed using fully disposable Patient specific cutting guides (PSCG-D) Receives: Device: GMK Medacta Total Knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
HKA angle
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 Hip-Knee-Ankle (HKA) 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 (3)
% outliers
% of patients with an HKA angle outside 180°+/- 3°
Measured: 3 months
Knee Society Score
Validated pain and function score following TKA
Measured: 3 months
Oxford Knee Score
Patients self assessment of knee function
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 posted17 Nov 2016 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionSep 2016
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,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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochin Hospital
- Responsible party
- Principal investigator, Moussa Hamadouche, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966613
- Sponsor's protocol ID
- SC2900
- Acronym
- MyKnee
- Status last verified
- Nov 2016
- First submitted
- 26 Sep 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Abane L, Zaoui A, Anract P, Lefevre N, Herman S, Hamadouche M. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. 2018 Jul;33(7):2111-2118. doi: 10.1016/j.arth.2018.02.038. Epub 2018 Feb 17.
PubMed 29576488
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study
- ClinicalTrials.gov ID
- NCT02966613
- Acronym / sponsor ID
- MyKnee / SC2900
- Conditions
- Osteoarthritis,Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Cochin Hospital
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Nov 2016 (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.
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.
Detailed description
The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CI | Active comparator | Device: GMK Medacta Total Knee arthroplastyTKA using conventional instrumentation (CI) |
| PSCG | Experimental | Device: GMK Medacta Total Knee arthroplastyTKA performed using Patient specific cutting guides (PSCG) |
| PSCG-D | Experimental | Device: GMK Medacta Total Knee arthroplastyTKA performed using fully disposable Patient specific cutting guides (PSCG-D) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged between 18 and 85 years
- able to understand information
- affiliated to social security
Key exclusion criteria (5 listed)
- active or suspected sepsis
- tumor around the knee
- previous partial or total knee replacement
- extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
- social situation that could impair follow-up
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 |
|---|---|---|
| GMK Medacta Total Knee arthroplastyTotal Knee arthroplasty | Device | CI, PSCG, PSCG-D |
Primary outcome
HKA angle
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 Hip-Knee-Ankle (HKA) 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.
3 secondary outcomes
% outliers
Time frame: 3 months
Knee Society Score
Time frame: 3 months
Oxford Knee Score
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 17 Nov 2016.
- Derived from this study: PubMed 29576488Abane L, Zaoui A, Anract P, Lefevre N, Herman S, Hamadouche M. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. 2018 Jul;33(7):2111-2118. doi: 10.1016/j.arth.2018.02.038. Epub 2018 Feb 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GMK Medacta Total Knee arthroplasty 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 3 inclusion and 5 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 17 Nov 2016. 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?
HKA angle (time frame: 3 months). 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 NCT02966613, 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 17 Nov 2016.