New bone cement tested for hip and knee implants
NCT ID NCT06699134
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is checking how well a special bone cement (Hi-Fatigue G with gentamicin) works in people getting hip or knee replacements. Researchers will look at X-rays and patient surveys to see if the cement helps implants stay in place and reduces problems. About 90 adults who already had or will have surgery with this cement are being followed for up to 5 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hi-Fatigue G bone cement with gentamicin
- What this could lead to
- If successful, this could confirm that the bone cement is safe and effective for use in hip and knee replacements, helping surgeons choose a reliable option.
- What could go wrong
- This is a small, retrospective study (90 people) that only looks back at existing data, so it cannot prove cause and effect. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Klinikum Weiden
RECRUITINGWeiden, Bavaria, 92637, Germany