Revision ArthroplastyNCT06699160
Refobacin Revision-3 Bone Cement Post-Market Study
An observational study of Revision Arthroplasty, run by Zimmer Biomet at 1 site in Netherlands.
Trial summary
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Arthroplasty
- What is being tested?
- Revision arthroplasty
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2025to Dec 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The population target is all subjects undergoing knee or hip revision surgeries with Refobacin® Revision-3 and a Zimmer Biomet implant approved for revision cases and who meet all of the inclusion and none of the exclusion criteria. Patients requiring a Zimmer Biomet StageOne™ spacer during a two-stage revision will be enrolled for subgroup analysis too.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on:
- removal of any metal components of the hip or knee implants used in combination with the cement
- frequency and incidence of adverse events
- overall pain and functional performance, subject quality of life, and radiographic parameters
Read the detailed description
Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures.
Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.
- Conditions
- Revision Arthroplasty
- Being tested
- Revision arthroplasty
- Keywords
- revision surgery, bone cement, Refobacin Revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision arthroplastyDevice
Also called Revision, Revision surgery
Hip or knee revision surgery resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
- removal of any metal components of the hip or knee implants used in combination with the cement
- frequency and incidence of adverse events
Measured: 3, 5 and 10 years post-operatively
Secondary outcomes (3)
EuroQuol 5D (EQ-5D) Score
Subject quality of life assessed through the completion of an EQ-5D questionnaire, when available
Measured: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Harris Hip Score / Knee Society Score
Pain and functional performance assessed through the completion of an Harris Hips Score (HHS) or Knee Society Score (KSS) questionnaires, when available, depending on whether the revision procedure was performed on hip or knee
Measured: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Radiographic evaluation
Radiographic evaluation, when available, include but is not limited to: radiolucency, cement mantle, osteolysis, atrophy, hypertrophy, migration/subsidence and heterotopic ossification.
Measured: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study startAug 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: The study was discontinued upon availability of relevant data through bespoke reporting, which fulfilled the study's primary objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision ArthroplastyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Clin Op Dir, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699160
- Sponsor's protocol ID
- CME2021-28C
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation
- ClinicalTrials.gov ID
- NCT06699160
- Acronym / sponsor ID
- CME2021-28C
- Conditions
- Revision Arthroplasty
- Keywords
- revision surgery, bone cement, Refobacin Revision
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was discontinued upon availability of relevant data through bespoke reporting, which fulfilled the study's primary objectives
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Nov 2024 (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.
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on:
- removal of any metal components of the hip or knee implants used in combination with the cement
- frequency and incidence of adverse events
- overall pain and functional performance, subject quality of life, and radiographic parameters
Detailed description
Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures.
Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population target is all subjects undergoing knee or hip revision surgeries with Refobacin® Revision-3 and a Zimmer Biomet implant approved for revision cases and who meet all of the inclusion and none of the exclusion criteria. Patients requiring a Zimmer Biomet StageOne™ spacer during a two-stage revision will be enrolled for subgroup analysis too.
Key inclusion criteria (10 listed)
- 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):
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Revision arthroplastyAlso: Revision, Revision surgeryHip or knee revision surgery resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains. | Device | – |
Primary outcome
Survivorship
Time frame: 3, 5 and 10 years post-operatively
* removal of any metal components of the hip or knee implants used in combination with the cement * frequency and incidence of adverse events
3 secondary outcomes
EuroQuol 5D (EQ-5D) Score
Time frame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Harris Hip Score / Knee Society Score
Time frame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Radiographic evaluation
Time frame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Related trials for Revision Arthroplasty
Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Active, not recruitingObservational study
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
Not yet recruiting
Watson Extraction System for Femoral Stem Extraction
Revision Arthroplasty
Not yet recruitingObservational study
Persona Revision Knee System EMEA PMCF Study
Severe Knee Pain, Severe Knee Disability
Recruiting
Fiber Smoothie Supplement
Total Knee Arthroplasty Revision, Inflammatory Markers
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. This study is not recruiting at the moment.
Emilie Rohmer, Clin Op Dir study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision Arthroplasty, run by Zimmer Biomet at 1 site in Netherlands.
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 10 inclusion and 12 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: withdrawn, as of the sponsor's last update on 25 Nov 2025. 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 Netherlands. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 3, 5 and 10 years post-operatively). 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 25 Nov 2025.