Knee cement checked: simplex HV holds up over two years
NCT ID NCT05659329
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked back at 200 patients who had a knee replacement using Simplex HV bone cement. The goal was to see if the cement kept the implant in place without needing a second surgery within two years. Researchers also measured knee motion and function using the Knee Society Score. The study is complete and provides real-world data on how this cement performs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simplex HV bone cement (with or without gentamicin)
- What this could lead to
- If results are positive, it may confirm that this bone cement is a reliable option for fixing knee implants, supporting its continued use.
- What could go wrong
- This is a retrospective review, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients or other bone cements.
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
-
200 people
The number who actually took part.
- Started
-
Apr 2016
- Finished
-
Sep 2022
- Lead sponsor
-
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
The study population will include all non-censored subjects who have received the Triathlon total knee system cemented with Simplex HV and are available for objective analysis.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * The Patient is age 18 or over at time of study device implantation * Patients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on label * Patients who have been followed for at least 24 months postoperatively Exclusion Criteria: * Patients who have undergone revision surgery * Patients who have undergone bilateral Knee Arthroplasty * Patients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for use * Patient has a cementless tibial baseplate. * Patient has an active or suspected latent infection in or about the affected knee joint * Patient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable risk * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days) * Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failure * Patient is a prisoner
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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