Evaluation of the 5C® MEDic Knee System

NCT07491575 | Recruiting

• 1 other identifier: S70873
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

5C® MEDic

Outcome Measures

Primary Outcomes (1)

• 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).

  From Surgical intervention to end of study at 5 years post-operative

Secondary Outcomes (6)

• EQ-5D-3L health questionnaire as clinical performance assessment

  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

  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

  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

  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

  From enrollment to a 1-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year))

Study Arms (1)

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

Device: 5C® Knee System prothesis

Interventions

5C® Knee System prothesis DEVICE

During the surgical intervention in this study, the 5C® Knee System prothesis is used.

Patients receiving the 5C® MEDic Knee System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Officials

• Hazem Wafa, Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazem Wafa, Dr.

CONTACT

+32 16 33 88 73; hazem.wafa@uzleuven.be

Anna Tarasiuk

CONTACT

+32 16 33 88 18; orthopedie.research@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035
• Last Updated: July 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)