Knee Replacement Clinical Trials

Clinical trials related to Knee Replacement Procedure

Evaluation of the Midterm Results of the 5C® MEDic Knee System

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Universitaire Ziekenhuizen KU Leuven
RECRUITING
Leuven
Contact Information
Primary
Hazem Wafa, Dr.
hazem.wafa@uzleuven.be
+32 16 33 88 73
Backup
Anna Tarasiuk
orthopedie.research@uzleuven.be
+32 16 33 88 18
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2035-04
Participants
Target number of participants: 100
Treatments
Experimental: Patients receiving the 5C® MEDic Knee System
Patients who will be operated at the Leuven University Hospital for a total knee arthroplasty and receive the 5C® MEDic Knee System
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov