Osteoarthritis of the KneeNCT06715917
Multicentre GMK UNI Anatomical Cementless Study - FR
An observational study of Osteoarthritis of the Knee and Avascular Necrosis of the Femoral Condyle, run by Medacta International SA at 5 sites in 2 countries.
Trial summary
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle, Revision Surgery
- How many people
- 249 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Mar 2017to 6 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the inclusion/exclusion criteria to take part to the current clinical study will be invited to participate before the surgery.
Who may be able to join
- Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
- Patient's age between 18 and 75 years old;
- Patients must be willing to comply with the pre and postoperative evaluation schedule.
Who cannot join
- Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
- Any patient who cannot or will not provide informed consent for participation in the study;
- Patients who need a revision surgery
- Patients unable to understand and take action;
- Any case not described in the inclusion criteria;
- Patients aged under 18 years;
- Patients aged over 75 years;
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Clinique Saint Vincent de Paul
Bourgoin, 38300
Polyclinique du Parc
Caen, 14000
Clinique du Mail
La Rochelle, 17000
Centre Orthéo
Saint-Etienne, 42100
About this study
Official title: PROSPECTIVE, MULTICENTRE POST-MARKETING SURVEILLANCE STUDY to ASSESS PERFORMANCE of the GMK UNI ANATOMICAL CEMENTLESS IMPLANT
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
New Knee Society Score (KSS)
The new Knee Society Knee Scoring System is both physician and patient derived. It includes versions to be administered preoperatively and postoperatively. It has an initial assessment of demographic details, including an expanded Charnley functional classification. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations. Given the diverse activity profiles of many contemporary patients, the functional component of the score was improved to include a patient-specific survey, which evaluates features such as standard activities of daily living, patient-specific sports and recreational activities, patient satisfaction, and patient expectations
Measured: Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
Secondary outcomes (3)
Kujala Score
The "Kujala Score" is the eponymous name for the Anterior Knee Pain Scale (AKPS). It is a patient-reported outcome survey and diagnostic tool that aims to assess the severity of symptoms and physical limitations in patients with patellofemoral pain syndrome (PFPS). The Kujala Score is a self-administered questionnaire for PFPS patients consisting of 13 questions that relate to specified activities, pain severity, and clinical symptoms. It is scored out of 100 points, which represents the summation of the scores for each individual question
Measured: 3 months, 1, 2, 3, 5, 7 and 10 years
Survival of the implant
Survival rate assessed with Kaplan Meier analysis
Measured: 3 months, 1, 2, 3, 5, 7 and 10 years
Safety of the implant
Recording of any adverse event and complication (including but not limited to: infection, loosening, deep venous thrombosis (DVT), fracture, reflex sympathetic dystrophy syndrome (RSD).)
Measured: Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 Mar 2017
- Primary completion6 Mar 2032 (estimated)
- Study completion6 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715917
- Sponsor's protocol ID
- P02.018.02
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE, MULTICENTRE POST-MARKETING SURVEILLANCE STUDY to ASSESS PERFORMANCE of the GMK UNI ANATOMICAL CEMENTLESS IMPLANT
- ClinicalTrials.gov ID
- NCT06715917
- Acronym / sponsor ID
- P02.018.02
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 6 Mar 2032 (estimated)
- Study completion
- 6 Mar 2032 (estimated)
- First posted
- 4 Dec 2024 (actual)
- 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 Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion/exclusion criteria to take part to the current clinical study will be invited to participate before the surgery.
Key inclusion criteria (4 listed)
- Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
- Patient's age between 18 and 75 years old;
- Patients must be willing to comply with the pre and postoperative evaluation schedule.
Key exclusion criteria (7 listed)
- Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
- Any patient who cannot or will not provide informed consent for participation in the study;
- Patients who need a revision surgery
- Patients unable to understand and take action;
- Any case not described in the inclusion criteria;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
New Knee Society Score (KSS)
Time frame: Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
The new Knee Society Knee Scoring System is both physician and patient derived. It includes versions to be administered preoperatively and postoperatively. It has an initial assessment of demographic details, including an expanded Charnley functional classification. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations. Given the diverse activity profiles of many contemporary patients, the functional component of the score was improved to include a patient-specific survey, which evaluates features such as standard activities of daily living, patient-specific sports and recreational activities, patient satisfaction, and patient expectations
3 secondary outcomes
Kujala Score
Time frame: 3 months, 1, 2, 3, 5, 7 and 10 years
Survival of the implant
Time frame: 3 months, 1, 2, 3, 5, 7 and 10 years
Safety of the implant
Time frame: Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Knee and Avascular Necrosis of the Femoral Condyle, run by Medacta International SA at 5 sites in 2 countries.
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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
New Knee Society Score (KSS) (time frame: Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years). 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 16 Dec 2024.