Osteoarthritis, KneeNCT03522025
GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs
A study testing Unicompartmental Knee Arthroplasty (UKA) in people with Osteoarthritis, Knee, run by Medacta International SA at 5 sites in 2 countries.
Trial summary
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the 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 95 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Unicompartmental Knee Arthroplasty (UKA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Feb 2019to 1 Dec 2026
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use according to Medacta implants included in this study (on-label use);
- Those suffering from unilateral osteoarthritis or osteonecrosis of the medial compartment;
- Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays);
- Flexion contracture < 10°;
- Intact ligaments;
- 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;
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- Patient's age over 18 years old;
- Patient with BMI < 40 kg/m2;
- Patients must be willing to comply with the pre and post-operative 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 to undergo lateral unicompartmental knee arthroplasty;
- Patients who need a revision surgery;
- Patients who need a patella-femoral joint prosthesis;
- Patients who had previously undergone high tibial osteotomy or ACL reconstruction;
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- Patients with BMI ≥ 40 kg/m2;
- Patients unable to understand and take action;
- Any case not described in the inclusion criteria;
- Patients aged under 18 years;
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Clinique Saint Vincent de Paul
Bourgoin, France, 38300
Clinique du Mail
La Rochelle, France, 17000
Centre Orthéo, Espace Fauriel
Saint-Etienne, France, 42100
CHP Saint-Grégoire
Saint-Grégoire, France, 35760
About this study
Official title: A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.
Read the detailed description
The Primary objective is to compare the quality of fixation of cemented and cementless designs of GMK-UNI unicompartmental knee replacement at 2 years of follow-up.
The Secondary objectives include the evaluation of the patient improvement (subjective and objective) using the new Knee Society Score (KSS); the patient's anterior pain following UKA and any eventual patella-femoral disorder; Implant survival rate using the Kaplan Meier analysis; Post-op radiological findings and Adverse Events.
The Primary outcome aims to compare the occurrence of radiolucency's lines (both partial and complete) between the two study groups. Secondary outcomes include New KSS, OKS, Kaplan Meier analysis and stability and fixation of UNI prosthesis.
All patients who meet the inclusion criteria to take part in the current clinical study will be invited to participate before the surgery.
Subjects will be randomized during the screening; half of them will receive the cemented GMK-UNI anatomical UKA and the other half the cementless GMK-UNI anatomical UKA.
Clinical data will be recorded on CRF at those time-points:
- Before the surgery
- During the surgery
- After the surgery at 3 months, 1, 2, 3 and 5 years.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Unicompartmental Knee Arthroplasty (UKA)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental Knee Arthroplasty (UKA)Device
Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| GMK-UNI cemented fixation prosthesis | Active comparator | Unicompartmental Knee Arthroplasty (UKA) Receives: Device: Unicompartmental Knee Arthroplasty (UKA) |
| GMK-UNI cementless fixation prosthesis | Experimental | Unicompartmental Knee Arthroplasty (UKA) Receives: Device: Unicompartmental Knee Arthroplasty (UKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the occurrence of radiolucency's lines
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
Measured: 5 yrs
Secondary outcomes (6)
Anterior Knee Pian Scale (Kujala score)
It's a 13-item knee specific self-report questionnaire. It documents response to 6 activities associated with anterior knee pain as well as symptoms such as limp, inability to weight bear through the affected limp, swelling...). It asks about duration of symptoms and limbs affected. Max score is 100 and lower scores indicate greater pain/disability. Scoring is hierarchical using various types of categorisation including "no difficulty-unable " and "no pain-severe pain". It is easy to understand and takes few minutes to complete.It has a good test-retest reliability.
Measured: pre-op; 3months;1,2,3,5 yrs
Implant survival rate using Kaplan Meier analysis
Implant survival rate
Measured: 5 yrs
Recording of adverse events
Any complication occurred during the study
Measured: Throughout the study
Oxford Knee Score
The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty).Each question is scored from 1 to 5, with 1 representing best outcome/least symptoms. Scores from each question are added so the overall score is from 12 to 60 (12 being the best outcome). The overall score for the OKS is acquired by simply summing the scores received for individual questions.
Measured: Pre-op;3month;1,2,3,5yrs
New Knee Society Score
The new KSS System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty.It includes versions to be admninstered pre-op and post-op.It has an initial assessment of demographic deatils. The objective knee score includes VAS score of pain walking on level ground and on stairs or inclines, as well as ROM, an assessment of alignment, ligament stability along with deductions for flexion contracture or extensor lag. Pts then record their satisfaction, functional activities and expectations. It consists of 4 subscales: 1) objective knee score (7 items;100 points); 2) Satisfaction Score (5 items; 40 points);3) Expectation Score (3 items; 15 points); 4) Functional Activity Score (19 items; 100 points)
Measured: Pre-op:3months;1,2,3,5 yrs
Stability and fixation of unicompartmental prosthesis
To evaluate the stability and fixation of the prosthesis
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 Feb 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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.
- More trials run by Medacta International SAThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT03522025
- Sponsor's protocol ID
- 2017-01677
- Other IDs
- 2017
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2018
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
- ClinicalTrials.gov ID
- NCT03522025
- Acronym / sponsor ID
- 2017-01677
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 May 2018 (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 the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.
Detailed description
The Primary objective is to compare the quality of fixation of cemented and cementless designs of GMK-UNI unicompartmental knee replacement at 2 years of follow-up.
The Secondary objectives include the evaluation of the patient improvement (subjective and objective) using the new Knee Society Score (KSS); the patient's anterior pain following UKA and any eventual patella-femoral disorder; Implant survival rate using the Kaplan Meier analysis; Post-op radiological findings and Adverse Events.
The Primary outcome aims to compare the occurrence of radiolucency's lines (both partial and complete) between the two study groups. Secondary outcomes include New KSS, OKS, Kaplan Meier analysis and stability and fixation of UNI prosthesis.
All patients who meet the inclusion criteria to take part in the current clinical study will be invited to participate before the surgery.
Subjects will be randomized during the screening; half of them will receive the cemented GMK-UNI anatomical UKA and the other half the cementless GMK-UNI anatomical UKA.
Clinical data will be recorded on CRF at those time-points:
- Before the surgery
- During the surgery
- After the surgery at 3 months, 1, 2, 3 and 5 years.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMK-UNI cemented fixation prosthesis | Active comparator | Device: Unicompartmental Knee Arthroplasty (UKA)Unicompartmental Knee Arthroplasty (UKA) |
| GMK-UNI cementless fixation prosthesis | Experimental | Device: Unicompartmental Knee Arthroplasty (UKA)Unicompartmental Knee Arthroplasty (UKA) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use according to Medacta implants included in this study (on-label use);
- Those suffering from unilateral osteoarthritis or osteonecrosis of the medial compartment;
- Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays);
- Flexion contracture < 10°;
- Intact ligaments;
Key exclusion criteria (10 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 to undergo lateral unicompartmental knee arthroplasty;
- Patients who need a revision surgery;
- Patients who need a patella-femoral joint 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 |
|---|---|---|
| Unicompartmental Knee Arthroplasty (UKA)Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis. | Device | GMK-UNI cemented fixation prosthesis, GMK-UNI cementless fixation prosthesis |
Primary outcome
Comparing the occurrence of radiolucency's lines
Time frame: 5 yrs
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
6 secondary outcomes
Anterior Knee Pian Scale (Kujala score)
Time frame: pre-op; 3months;1,2,3,5 yrs
Implant survival rate using Kaplan Meier analysis
Time frame: 5 yrs
Recording of adverse events
Time frame: Throughout the study
Oxford Knee Score
Time frame: Pre-op;3month;1,2,3,5yrs
New Knee Society Score
Time frame: Pre-op:3months;1,2,3,5 yrs
Stability and fixation of unicompartmental prosthesis
Time frame: 5 yrs
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 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Unicompartmental Knee Arthroplasty (UKA) in people with Osteoarthritis, Knee, 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 9 inclusion and 10 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 25 Sep 2025. 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?
Comparing the occurrence of radiolucency's lines (time frame: 5 yrs). 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 25 Sep 2025.