Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06699160
Eligibility Criteria:
Inclusion Criteria:
* Patient is 18 years or older and skeletally mature.
* Patient is capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program.
* Patient gave consent to take part in the study by signing the Ethics Committee approved Informed Consent Form (ICF).
* Patient who underwent or will undergo a hip or knee revision surgery with a Zimmer Biomet implant and the Refobacin® Revision-3 Bone Cement.
* Patient meets at least one of the following indications, as stated in the Instructions for Use (IFU):
* Patients requires a revision operation resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.
* Patients undergoing a two-stage revision that requires the fabrication and fixation of short-term total or hemi joint StageOne™ spacers. The device is intended for use in conjunction with systemic antimicrobial therapy (standard approach to an infection).
Additional inclusion criteria for patients receiving a StageOne™ spacer, as stated in the IFU:
* Implantation period of a maximum of 180 days.
* The molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Exclusion Criteria:
* Patient is unwilling or unable to give consent or to comply with the follow-up program.
* Patient is known to be pregnant or breastfeeding.
* Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
* Patient has plans to relocate during the study follow-up period.
* As stated in the IFU, patient with known hypersensitivity to gentamicin and/or clindamycin and/or to other constituents of the bone cement.
* Additional exclusion criteria for patients receiving a StageOne™ spacer, as stated in the IFU:
* The infected Total Hip/Knee Replacement (THR/TKR) devices cannot be removed.
* A systemic or secondary remote infection is expected or confirmed.
* Lack of adequate bone structure precludes adequate support of the prosthesis in the proximal femur or acetabular region, or
* Lack of adequate competence (anatomical and functional) of peripheral ligamentous apparatus and extensor mechanism.
* The patient is sensitive (allergic) to aminoglycosides.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06699160
Study Brief:
Protocol Section:
NCT06699160