Total Hip and Knee ArthroplastiesNCT06699134
Hi-Fatigue G Bone Cement Retrospective Study
An observational study of Total Hip and Knee Arthroplasties, run by Zimmer Biomet at 1 site in Germany.
Trial summary
The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip and Knee Arthroplasties
- What is being tested?
- Total knee arthroplasty and Total Hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 19 Nov 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients operated with primary total knee or hip replacement using Hi-Fatigue G Bone Cement, a Zimmer Biomet implant, and who meet the inclusion / exclusion criteria for study participation. Two consecutive groups of patients that underwent cemented TKA or THA according to the instructions for use of both the respective implant and of Hi-Fatigue G Bone Cement.
Who may be able to join
- Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
- Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \& Scores completion)
- Subject > 18 years old
Who cannot join
- Muscle wasting
- Neuromuscular compromise in the affected limb
- Known hypersensitivity to any of the cement constituents
- Subjects with severe renal failure
- Bilateral interventions
- Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Weiden
Weiden, Bavaria, 92637
Christian von Rüden, 00490961 303-0, christian.vonrueden@kno.ag
About this study
Official title: Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.
The assessments will include:
Read more
- Radiological analysis performed at different time points according to the standard of care of the hospital
- Implant survivorship and safety based on removal of a study device
- Patient reported outcome measures (PROMs)
Primary endpoint:
Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
Secondary endpoints:
- Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
- Evaluation of PROMs
- Obtain information regarding the cementing technique and handling of the cement, if available
- Conditions
- Total Hip and Knee Arthroplasties
- Being tested
- Total knee arthroplasty, Total Hip arthroplasty
- Keywords
- Bone Cement, Knee Arthroplasty, Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDevice
Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Total Hip arthroplastyDevice
Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
| Study group | Role | What they receive |
|---|---|---|
| Patients with TKA | Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant Receives: Device: Total knee arthroplasty | |
| Patients with THA | Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant Receives: Device: Total Hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation
Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
Measured: From enrollment to the 5 year post-op follow up.
Secondary outcomes (3)
Survivorship
Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
Measured: From enrollment to the 5 year post-op follow up.
Patient reported outcome measures (PROM)
Evaluation of PROMs, collected in accordance with the hospital standard of care.
Measured: From enrollment to the 5 year post-op follow up.
Cement Information
Obtain information regarding the cementing technique and handling of the cement, if available
Measured: From enrollment to the 5 year post-op follow up.
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 start19 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip and Knee ArthroplastiesStudies 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
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699134
- Sponsor's protocol ID
- CME2020-38C
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
- ClinicalTrials.gov ID
- NCT06699134
- Acronym / sponsor ID
- CME2020-38C
- Conditions
- Total Hip and Knee Arthroplasties
- Keywords
- Bone Cement, Knee Arthroplasty, Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (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 objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.
The assessments will include:
- Radiological analysis performed at different time points according to the standard of care of the hospital
- Implant survivorship and safety based on removal of a study device
- Patient reported outcome measures (PROMs)
Primary endpoint:
Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
Secondary endpoints:
- Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
- Evaluation of PROMs
- Obtain information regarding the cementing technique and handling of the cement, if available
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with TKA | – | Device: Total knee arthroplastyPatients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant |
| Patients with THA | – | Device: Total Hip arthroplastyPatients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated with primary total knee or hip replacement using Hi-Fatigue G Bone Cement, a Zimmer Biomet implant, and who meet the inclusion / exclusion criteria for study participation. Two consecutive groups of patients that underwent cemented TKA or THA according to the instructions for use of both the respective implant and of Hi-Fatigue G Bone Cement.
Key inclusion criteria (3 listed)
- Subject qualified for cemented TKA or THA with a Zimmer Biomet implant
- Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \& Scores completion)
- Subject > 18 years old
Key exclusion criteria (6 listed)
- Muscle wasting
- Neuromuscular compromise in the affected limb
- Known hypersensitivity to any of the cement constituents
- Subjects with severe renal failure
- Bilateral interventions
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 |
|---|---|---|
| Total knee arthroplastyPrimary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant | Device | Patients with TKA |
| Total Hip arthroplastyPrimary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant | Device | Patients with THA |
Primary outcome
Radiographic evaluation
Time frame: From enrollment to the 5 year post-op follow up.
Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).
3 secondary outcomes
Survivorship
Time frame: From enrollment to the 5 year post-op follow up.
Patient reported outcome measures (PROM)
Time frame: From enrollment to the 5 year post-op follow up.
Cement Information
Time frame: From enrollment to the 5 year post-op follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Related trials for Total Hip and Knee Arthroplasties
Active, not recruiting
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Arthritis Knee, Arthritis Hip
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
RecruitingObservational study
The Effect of Perioperative Nutritional Care on Recovery After Knee and Hip Replacement Surgery
Postoperative Outcomes, Postoperative Complications
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
Not yet recruiting
The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty
Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting
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.
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 Total Hip and Knee Arthroplasties, run by Zimmer Biomet at 1 site in Germany.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Dec 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel Correa-Tapia (+41791522905, Miguel.CorreaTapia@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic evaluation (time frame: From enrollment to the 5 year post-op follow up.). 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 2 Dec 2025.