Knee Degenerative Disease5C KneeNCT07491575
Evaluation of the 5C® MEDic Knee System
A study testing 5C® Knee System prothesis in people with Knee Degenerative Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This prospective study wants to demonstrate the safety and clinical performance of the 5C® MEDic Knee System following total knee arthroplasty. Additionally, all observed product-related complications are documented during the course of the follow-up study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Degenerative Disease
- What is being tested?
- 5C® Knee System prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2026to Apr 2035
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- The patient will be operated at the Leuven University Hospital (primary or revision surgery).
- The patient will receive the 5C® MEDic Knee System (manufactured by implantcast GmbH).
- The implantation will be performed according to the medical indications listed in the product specific Instruction for Use (IFU):
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
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- Post-traumatic osteoarthritis
- Treatment of fractures that are unmanageable using other surgical techniques
- Rheumatoid arthritis
- Revision arthroplasty (revision prosthesis)
- The patient is willing and able to follow all study specific procedures and to attend the follow-up visits at the study site
- The patient agrees to be contacted by telephone or by mail.
Who cannot join
- The patient is <18 years of age, or unable to understand and sign a written informed consent form or legally incompetent or limited in his legal capacity.
- Patient has history of malignancy within the past 5 years before screening.
- Patients with Adipositas permagna (BMI ≥40 kg/m²).
- Has a current infection as well as infections close (in the opinion of the investigator) to the knee joint within the last 3 years.
- Known allergy to any of the implant materials.
- Female who is pregnant or intends to become pregnant during screening and at the moment of operation
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- Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, as assessed by the Investigator.
- Current alcohol and/or drug abuse or other addictions that might impair the patient's capacity to estimate the nature and the scope of the study.
- Bilateral Total Knee Arthroplasty in a period of < 3 months.
- Physiological or anatomical conditions, which preclude or are not expected to maintain adequate bony support of the implant or do not allow the implantation of a sufficiently large prosthesis, in the opinion of the investigator.
- Bone tumors in the implant fixation area.
- Has an untreated vascular diseases which limit blood supply to the affected limb, in the opinion of the investigator
- Has a metabolic disorders that may impair bone formation.
- In case of insufficient quantity and quality of bone stock, an alternative prosthetic treatment allowing for sufficient bony fixation should be considered.
- Has severe axis deviation in treated knee under study and/or non-treated knee.
- Ligament instability in treated knee under study.
- Participation in an interventional trial with an investigational medicinal product (IMP) or device within the last four weeks before Screening.
- Any other clinical history finding that, in the judgment of the investigator, would pose a potential hazard for performing a knee surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000
Hazem Wafa, Dr., +32 16 33 88 73, hazem.wafa@uzleuven.be
Anna Tarasiuk, +32 16 33 88 18, orthopedie.research@uzleuven.be
About this study
Official title: Evaluation of the Midterm Results of the 5C® MEDic Knee System
This prospective study wants to demonstrate the safety and clinical performance of the 5C® MEDic Knee System following total knee arthroplasty. Additionally, all observed product-related complications are documented during the course of the follow-up study. These observations help to re-assess current (known) risks and identify new ones. The data obtained during this study is part of the post market surveillance.
Read the detailed description
Despite significant advancements in total knee replacement surgery, patient-reported satisfaction rates remain around 80-90%. The native knee joint kinematics are driven by the asymmetric articular surfaces where the medial tibial plateau is concave while the lateral is convex. The C-shaped medial meniscus has anterior and posterior lips that resist translation while the lateral meniscus has a circular shape allowing for 15° of anterior to posterior motion and an 11 mm of translation. As the knee flexes, the medial femoral condyle has a static centre of rotation without anteroposterior translation while the lateral femoral condyle translates posteriorly resulting in relative internal rotation of the tibia around a medial pivot.
The design of medial pivot knee prosthesis closely replicates these native knee kinematics. The medial ball in-socket design offers a highly conforming implant resulting in low contact stress and minimal edge loading.
On the other hand, the lateral arcuate trough provides less conformity therefore facilitating posterior translation of the lateral contact point during flexion recreating the native posterior femoral rollback. Over recent years, the medial pivot knee arthroplasty has gained popularity with multiple studies reporting enhanced patients' reported outcomes compared to other designs. Despite the favourable outcomes reported in the literature, there is still lack of sufficient data in the literature regarding the reported patient's outcomes and the overall revision rate of these medial pivot designs.
This prospective study wants to demonstrate the safety and clinical performance of the 5C® MEDic Knee System following total knee arthroplasty. Additionally, all observed product-related complications are documented during the course of the follow-up study. These observations help to re-assess current (known) risks and identify new ones. The data obtained during this study is part of the post market surveillance.
- Conditions
- Knee Degenerative Disease
- Being tested
- 5C® Knee System prothesis
- Keywords
- 5C® MEDic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5C® Knee System prothesisDevice
During the surgical intervention in this study, the 5C® Knee System prothesis is used.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving the 5C® MEDic Knee System | Experimental | Patients who will be operated at the Leuven University Hospital for a total knee arthroplasty and receive the 5C® MEDic Knee System Receives: Device: 5C® Knee System prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate after the 5C® MEDic Knee System
The Implant Survival of the 5C® MEDic Knee System prothesis is determined by the amount of revisions during the follow-up period of 5 years. The question, if a revision is performed after the surgical intervention, can be answered with "yes" or "no". Also, how long the prosthesis remains in place without the need for a second operation (revision) is recorded (in years).
Measured: From Surgical intervention to end of study at 5 years post-operative
Secondary outcomes (6)
EQ-5D-3L health questionnaire as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The questionnaire will evaluate mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Every topic can be answered with "No", "Moderate", "not able to/Extreme". Additionally, patients provide a self-assessment of their overall health using a Visual Analogue Scale (VAS) from 0 to 100, where 0 represents the "worst health imaginable" and 100 represents the "best health imaginable."
Measured: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Forgotten Joint Score questionnaire (FJS-12) as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The questionnaire will evaluate "joint/prothesis awareness" during activities of daily living after total knee arthroplasty, meaning to which extent a patient is aware of their prosthetic joint. The questionnaire consists of 12 items, each rated on a 5-point scale (0-4). The total score is transformed to a 0-100 scale, where a higher score indicates a better outcome (i.e., the patient is less aware of the artificial joint).
Measured: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
High-Flexion Knee Score questionnaire as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The questionnaire will evaluate lifestyle activities that require deep knee flexion. This questionnaire assesses the patient's ability to perform functional tasks such as kneeling, squatting, and sitting cross-legged. The HFKS consists of several items categorized into functional domains, where higher scores represent superior clinical performance and greater ease in performing high-flexion movements.
Measured: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Knee Society Score questionnaire as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The Knee Society Score (KSS) is a assessment tool used to evaluate the outcomes of total knee arthroplasty (TKA). It consists of four distinct subscales:
- Objective Knee Score (completed by the surgeon, measuring alignment and ligament stability)
- Patient Satisfaction Score (measuring how happy the patient is with the outcome)
- Patient Expectation Score (measuring if the surgery met preoperative goals)
- Functional Activity Score (assessing walking, stair climbing, and advanced activities).
This approach-combining objective clinical data with patient-reported outcomes-provides a comprehensive overview of the prosthesis's performance and its impact on the patient's quality of life.
Measured: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Radiographic evaluation of the 5C® MEDic Knee System on X-ray images
The radiographic evaluation will be performed according to the "Knee Society Radiographic Evaluation System and Methodology for Total Knee Arthroplasty". The purpose of this scoring system is to accumulate radiographic data in a standardized manner to facilitate more accurate interpretation, documentation and clinical correlation.
Measured: From enrollment to a 1-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year))
Overwiew of complications and incidents during 5 years of follow-up
During surgery and the 5-year follow-up period the number and types of complications and incidents is collected.
Measured: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionApr 2035 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This post-market clinical follow-up (PMCF) study will focus on patients, who will be operated at the Leuven University Hospital and receive the 5C® MEDic Knee System
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem Wafa, Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491575
- Sponsor's protocol ID
- S70873
- Acronym
- 5C Knee
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with third parties to ensure de-identification and maintain strict patient confidentiality in accordance with the General Data Protection Regulation (GDPR). Due to the highly specific nature of complex primary and revision hip arthroplasty-sometimes involving rare congenital pathologies and unique skeletal deformities-sharing raw, granular data poses a significant risk of 'deductive re-identification.' Even without direct identifiers, the combination of rare clinical characteristics and surgical dates could potentially allow for the identification of individual patients. Therefore, only aggregated, pseudonymized data and statistical summaries will be provided for analysis and reporting.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Midterm Results of the 5C® MEDic Knee System
- ClinicalTrials.gov ID
- NCT07491575
- Acronym / sponsor ID
- 5C Knee / S70873
- Conditions
- Knee Degenerative Disease
- Keywords
- 5C® MEDic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 24 Mar 2026 (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.
This prospective study wants to demonstrate the safety and clinical performance of the 5C® MEDic Knee System following total knee arthroplasty. Additionally, all observed product-related complications are documented during the course of the follow-up study. These observations help to re-assess current (known) risks and identify new ones. The data obtained during this study is part of the post market surveillance.
Detailed description
Despite significant advancements in total knee replacement surgery, patient-reported satisfaction rates remain around 80-90%. The native knee joint kinematics are driven by the asymmetric articular surfaces where the medial tibial plateau is concave while the lateral is convex. The C-shaped medial meniscus has anterior and posterior lips that resist translation while the lateral meniscus has a circular shape allowing for 15° of anterior to posterior motion and an 11 mm of translation. As the knee flexes, the medial femoral condyle has a static centre of rotation without anteroposterior translation while the lateral femoral condyle translates posteriorly resulting in relative internal rotation of the tibia around a medial pivot.
The design of medial pivot knee prosthesis closely replicates these native knee kinematics. The medial ball in-socket design offers a highly conforming implant resulting in low contact stress and minimal edge loading.
On the other hand, the lateral arcuate trough provides less conformity therefore facilitating posterior translation of the lateral contact point during flexion recreating the native posterior femoral rollback. Over recent years, the medial pivot knee arthroplasty has gained popularity with multiple studies reporting enhanced patients' reported outcomes compared to other designs. Despite the favourable outcomes reported in the literature, there is still lack of sufficient data in the literature regarding the reported patient's outcomes and the overall revision rate of these medial pivot designs.
This prospective study wants to demonstrate the safety and clinical performance of the 5C® MEDic Knee System following total knee arthroplasty. Additionally, all observed product-related complications are documented during the course of the follow-up study. These observations help to re-assess current (known) risks and identify new ones. The data obtained during this study is part of the post market surveillance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This post-market clinical follow-up (PMCF) study will focus on patients, who will be operated at the Leuven University Hospital and receive the 5C® MEDic Knee System
| Arm | Type | Receives |
|---|---|---|
| Patients receiving the 5C® MEDic Knee System | Experimental | Device: 5C® Knee System prothesisPatients who will be operated at the Leuven University Hospital for a total knee arthroplasty and receive the 5C® MEDic Knee System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- The patient will be operated at the Leuven University Hospital (primary or revision surgery).
- The patient will receive the 5C® MEDic Knee System (manufactured by implantcast GmbH).
- The implantation will be performed according to the medical indications listed in the product specific Instruction for Use (IFU):
Key exclusion criteria (18 listed)
- The patient is <18 years of age, or unable to understand and sign a written informed consent form or legally incompetent or limited in his legal capacity.
- Patient has history of malignancy within the past 5 years before screening.
- Patients with Adipositas permagna (BMI ≥40 kg/m²).
- Has a current infection as well as infections close (in the opinion of the investigator) to the knee joint within the last 3 years.
- Known allergy to any of the implant materials.
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 |
|---|---|---|
| 5C® Knee System prothesisDuring the surgical intervention in this study, the 5C® Knee System prothesis is used. | Device | Patients receiving the 5C® MEDic Knee System |
Primary outcome
Revision rate after the 5C® MEDic Knee System
Time frame: From Surgical intervention to end of study at 5 years post-operative
The Implant Survival of the 5C® MEDic Knee System prothesis is determined by the amount of revisions during the follow-up period of 5 years. The question, if a revision is performed after the surgical intervention, can be answered with "yes" or "no". Also, how long the prosthesis remains in place without the need for a second operation (revision) is recorded (in years).
6 secondary outcomes
EQ-5D-3L health questionnaire as clinical performance assessment
Time frame: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Forgotten Joint Score questionnaire (FJS-12) as clinical performance assessment
Time frame: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
High-Flexion Knee Score questionnaire as clinical performance assessment
Time frame: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Knee Society Score questionnaire as clinical performance assessment
Time frame: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))
Radiographic evaluation of the 5C® MEDic Knee System on X-ray images
Time frame: From enrollment to a 1-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year))
Overwiew of complications and incidents during 5 years of follow-up
Time frame: From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 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 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with third parties to ensure de-identification and maintain strict patient confidentiality in accordance with the General Data Protection Regulation (GDPR). Due to the highly specific nature of complex primary and revision hip arthroplasty-sometimes involving rare congenital pathologies and unique skeletal deformities-sharing raw, granular data poses a significant risk of 'deductive re-identification.' Even without direct identifiers, the combination of rare clinical characteristics and surgical dates could potentially allow for the identification of individual patients. Therefore, only aggregated, pseudonymized data and statistical summaries will be provided for analysis and reporting.
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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.
Hazem Wafa, Dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5C® Knee System prothesis in people with Knee Degenerative Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 12 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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 Belgium. 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?
Contact Hazem Wafa, Dr. (+32 16 33 88 73, hazem.wafa@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate after the 5C® MEDic Knee System (time frame: From Surgical intervention to end of study at 5 years post-operative). 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 10 Jul 2026.