Knee ProsthesisPSI-PUCNCT02018484
Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.
A study testing Unicompartmental Knee Replacement in people with Knee Prosthesis, run by Rennes University Hospital at 1 site in France.
Trial summary
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Prosthesis
- What is being tested?
- Unicompartmental Knee Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to May 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
- patients aged 18 or older;
- indication of medial unicompartmental knee replacement (validated by the orthopedic surgeons staff) ;
- written informed consent.
Who cannot join
- MRI contraindication ;
- Absence of the main investigator or the associated scientist during the surgical procedure ;
- Adults under legal protective regimen or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence the position of the different elements of the prosthesis and the limb alignment. It is known that good positioning of the prosthesis is the key of a good survival of the implants. To guide the blade of the saw, cutting guides are used. The position of these guides gives the final position of the cuts. At present, two main techniques are used to position the guides: the conventional one, not very costly but not very accurate, and the navigated procedure, which is more accurate but also more expensive and more invasive. Since few years, patient specific cutting guides are used in total knee replacement with encouraging results and more recently in uni compartmental knee replacement with no scientific proof of efficiency.
This study aims to validate the procedure of patient specific cutting guides.
Read the detailed description
30 patients will be included in a mono centric, single-arm study with evaluation of the primary outcome by an independent expert comity. Each participant will have an MRI which will be sent to the society in charge of creating the patient specific cutting guides. The intervention will be performed using the patient specific cutting guides and in parallel, a station of navigation will be used to provide a safety control of the orientation of the cutting guide and to collect per operative data.
Evaluation visit is performed 6 months after surgery.
- Conditions
- Knee Prosthesis
- Being tested
- Unicompartmental Knee Replacement
- Keywords
- Surgery / Knee / Replacement / MRI / Specific cutting guides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental Knee ReplacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient specific cutting guides | Experimental | Unicompartmental knee replacement with patient specific cutting guides Receives: Procedure: Unicompartmental Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in performing the tibial cut
Success is defined as a correct orientation of the tibial cut which has to be within patient's target value (± 2°) at 6 months in both the frontal and the sagittal plans.
Failure of prosthesis implantation (defined by outranging patient's target value of more than 4º in the frontal or the sagittal plan or more than 3 mm on the cutting depth, controled by per operative navigated procedure) is considered as treatment failure.
Measured: Month 6
Secondary outcomes (2)
Success rate in conserving a residual varus.
Success is defined as a post-operative varus which does not exceed the patient's target value ± 3°, while respecting a 1° minimal varus.
Measured: Month 6
Variations of other orientation parameters of the tibial cut and limb alignment at the different times of the procedure (per and post operative) .
Measured: Per-operative, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies of the same condition, open and under way.
- More trials run by Rennes 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Lambotte, MD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, PhD, Study chair, CIC INSERM 0203 CHU de RENNES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018484
- Sponsor's protocol ID
- 2013-A01337-38
- Acronym
- PSI-PUC
- Status last verified
- Mar 2016
- First submitted
- 9 Dec 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.
- ClinicalTrials.gov ID
- NCT02018484
- Acronym / sponsor ID
- PSI-PUC / 2013-A01337-38
- Conditions
- Knee Prosthesis
- Keywords
- Surgery / Knee / Replacement / MRI / Specific cutting guides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 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.
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence the position of the different elements of the prosthesis and the limb alignment. It is known that good positioning of the prosthesis is the key of a good survival of the implants. To guide the blade of the saw, cutting guides are used. The position of these guides gives the final position of the cuts. At present, two main techniques are used to position the guides: the conventional one, not very costly but not very accurate, and the navigated procedure, which is more accurate but also more expensive and more invasive. Since few years, patient specific cutting guides are used in total knee replacement with encouraging results and more recently in uni compartmental knee replacement with no scientific proof of efficiency.
This study aims to validate the procedure of patient specific cutting guides.
Detailed description
30 patients will be included in a mono centric, single-arm study with evaluation of the primary outcome by an independent expert comity. Each participant will have an MRI which will be sent to the society in charge of creating the patient specific cutting guides. The intervention will be performed using the patient specific cutting guides and in parallel, a station of navigation will be used to provide a safety control of the orientation of the cutting guide and to collect per operative data.
Evaluation visit is performed 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient specific cutting guides | Experimental | Procedure: Unicompartmental Knee ReplacementUnicompartmental knee replacement with patient specific cutting guides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 18 or older;
- indication of medial unicompartmental knee replacement (validated by the orthopedic surgeons staff) ;
- written informed consent.
Key exclusion criteria (3 listed)
- MRI contraindication ;
- Absence of the main investigator or the associated scientist during the surgical procedure ;
- Adults under legal protective regimen or deprived of liberty.
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 |
|---|---|---|
| Unicompartmental Knee Replacement | Procedure or surgery | Patient specific cutting guides |
Primary outcome
Success rate in performing the tibial cut
Time frame: Month 6
Success is defined as a correct orientation of the tibial cut which has to be within patient's target value (± 2°) at 6 months in both the frontal and the sagittal plans. Failure of prosthesis implantation (defined by outranging patient's target value of more than 4º in the frontal or the sagittal plan or more than 3 mm on the cutting depth, controled by per operative navigated procedure) is considered as treatment failure.
2 secondary outcomes
Success rate in conserving a residual varus.
Time frame: Month 6
Variations of other orientation parameters of the tibial cut and limb alignment at the different times of the procedure (per and post operative) .
Time frame: Per-operative, and Month 6
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 19 Aug 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.
Jean-Christophe Lambotte, MD principal investigator
Rennes University Hospital
Bruno Laviolle, MD, PhD study chair
CIC INSERM 0203 CHU de RENNES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicompartmental Knee Replacement in people with Knee Prosthesis, run by Rennes 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 3 inclusion and 3 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 19 Aug 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 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?
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?
Success rate in performing the tibial cut (time frame: Month 6). 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 19 Aug 2016.