OsteoarthritisNCT01814384
Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
A study testing prosthesis GMK ® without the ancillary MyKnee ® LBS and Matched patient cutting blocks MyKnee ® LBS in people with Osteoarthritis, run by Nantes University Hospital at 1 site in France.
Trial summary
Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- prosthesis GMK ® without the ancillary MyKnee ® LBS and Matched patient cutting blocks MyKnee ® LBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.
Who cannot join
- distorded axes or laxity requiring the establishment of constrained prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.
Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.
Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.
- Conditions
- Osteoarthritis
- Being tested
- prosthesis GMK ® without the ancillary MyKnee ® LBS, Matched patient cutting blocks MyKnee ® LBS
- Keywords
- Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthesis GMK ® without the ancillary MyKnee ® LBSDevice
Matched patient cutting blocks MyKnee ® LBSDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS. Receives: Device: prosthesis GMK ® without the ancillary MyKnee ® LBS |
| Matched patient | Other | Treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS. Receives: Device: Matched patient cutting blocks MyKnee ® LBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.
Measured: 2 years after
Secondary outcomes (2)
to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
Measured: 2 years after
medico-economic evaluation type "Cost minimization"
- Compare the costs of implementing the two strategies (A and B) taking into account the resources consumed (operative time, anesthetic drugs, blood bags ...).
- Determine the least costly therapeutic intervention and medico-economic impact in the current system of financing of hospital expenditure.
Measured: 2 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814384
- Sponsor's protocol ID
- RC 12_0100
- Status last verified
- Sep 2015
- First submitted
- 11 Mar 2013
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.
- ClinicalTrials.gov ID
- NCT01814384
- Acronym / sponsor ID
- RC 12_0100
- Conditions
- Osteoarthritis
- Keywords
- Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Mar 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.
Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.
Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: prosthesis GMK ® without the ancillary MyKnee ® LBSControl group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS. |
| Matched patient | Other | Device: Matched patient cutting blocks MyKnee ® LBSTreated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.
Key exclusion criteria (1 listed)
- distorded axes or laxity requiring the establishment of constrained prosthesis
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 |
|---|---|---|
| prosthesis GMK ® without the ancillary MyKnee ® LBS | Device | Control group |
| Matched patient cutting blocks MyKnee ® LBS | Device | Matched patient |
Primary outcome
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
Time frame: 2 years after
The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.
2 secondary outcomes
to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
Time frame: 2 years after
medico-economic evaluation type "Cost minimization"
Time frame: 2 years after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prosthesis GMK ® without the ancillary MyKnee ® LBS and Matched patient cutting blocks MyKnee ® LBS in people with Osteoarthritis, run by Nantes University Hospital at 1 site in France.
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 4 Sep 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 France. 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?
compare the functionality of the knee after installation of a total knee replacement between the 2 groups (time frame: 2 years after). 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 4 Sep 2015.