The objectives of this study are to confirm safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement and its instrumentation, when used in hip or knee revision surgeries, by analysis of standard scoring systems, radiographs…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined by the survival of the implant system at 3, 5,
and 10 years which is based on removal of any metal components of the hip or
knee implants used in combination with the Refobacin Revision-3 Bone Cement and
will be determined using Kaplan Meier method.
The safety of the system will be assessed by monitoring the frequency and
incidence of adverse events. Relation of the events to bone cement, implant,
instrumentation and/or procedure should be specified.
Secondary outcome
The secondary endpoints of this study are defined by the performance and
clinical benefits of Refobacin Revision-3 Bone cement which will be assessed by
the standard scoring system (PROMs) at each follow up time-point.
Background summary
To prevent the development of a periprosthetic joint infection, Zimmer Biomet
has developed a bone cement called Refobacin Revision, which contains the
antibiotics clindamycin and gentamicin; the combination of the two antibiotics,
which target different kinds of bacteria, is known to have an antibacterial
effect on more than 90% of the bacteria common to infected cases.
This is a Post-Market Clinical Follow-up (PMCF) study to fulfil the post-market
surveillance obligations according to Medical Device Directive, MEDDEV 2.12-2
and the Medical Devices Regulation (MDR 2017/745). The data collected from this
study will serve the purpose of confirming safety, performance and clinical
benefits of the Refobacin Revision-3 and its instrumentations when used in hip
and knee revision surgeries.
Study objective
The objectives of this study are to confirm safety, performance and clinical
benefits of the Refobacin Revision-3 Bone Cement and its instrumentation, when
used in hip or knee revision surgeries, by analysis of standard scoring
systems, radiographs and adverse event records.
The safety of the system will be assessed by monitoring the frequency and
incidence of adverse events as well as any revision of cemented metal
components to the joint. Relation of the events to cement, implant,
instrumentation and/or procedure should be specified.
The performance and clinical benefits will be evaluated by assessment of the
overall pain and functional performance, subject quality of life, and
radiographic parameters of all enrolled study subjects.
Study design
Retrospective and prospective, consecutive, multicenter, non-controlled study.
Sub group: StageOne spacer cohort.
Study burden and risks
The foreseeable risks and possible side effects associated with surgery were
explained to you in details by your surgeon before the operation.
There are no additional risks related to your participation in the study.
The patients will have no direct benefit from taking part in this study.
However, the information we get from documenting the outcome of your surgery
will help us measure the safety and performance of this procedure and assess
whether it can provide long-term benefits to many other patients.
Participating in the study may have the following disadvantages:
- Participation in the study costs the patient extra time, because 2 additional
postoperative follow-up visits in the hospital are planned.
- These visits include taking an x-ray of the operated joint.
Zählerweg 4
Zug 6300
NL
Zählerweg 4
Zug 6300
NL
Listed location countries
Age
Inclusion criteria
• Patient is 18 years or older and skeletally mature.
• Patient is capable of understanding the surgeon*s explanations and following
his instructions, able and willing to participate in the follow-up program.
• Patient gave consent to take part in the study by signing the EC 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 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:
o Implantation period of a maximum of 180 days.
o 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06699160 |
| CCMO | NL87879.100.24 |