New knee implant could last longer without cement
NCT ID NCT02578446
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new uncemented knee replacement made with a porous metal called Tritanium, which may help bone grow into the implant for stronger fixation. It compares this to the standard cemented knee replacement in 72 patients with osteoarthritis. The goal is to see if the new implant moves less and lasts longer, potentially reducing the need for revision surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Uncemented Triathlon Tritanium CR Total Knee System (device) vs Cemented Triathlon CR Total Knee System (device)
- What this could lead to
- If successful, this could lead to a more durable knee replacement that lasts longer without loosening, especially for younger, active patients.
- What could go wrong
- This is a small, early-stage study (72 patients) comparing two devices. The new implant may not perform better than the standard cemented one, and long-term results are not yet available.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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72 people
The number who actually took part.
- Started
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Oct 2015
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- 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: 1. Patient is able to understand the meaning of the study and is willing to sign the Ethics Commission (EC) approved, study specific Informed Patient Consent Form. 2. Patients eligible and scheduled to undergo primary total knee replacement with any of the following indication. * Painful and disabled knee joint resulting from osteoarthritis (Ahlbäck stage II to V) * One or more compartments are involved. 3. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations. 4. A good nutritional state of the patient. 5. The subject is a male or non-pregnant female between 40 and 75 years of age. Exclusion Criteria: 1. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 37. 2. Previous major knee surgery 3. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 3 months ago with good outcome can be included in the study). 4. Patients with other severe concurrent joint involvements that can affect their outcome. 5. Patient has a flexion contracture of 15° and more. 6. Patient has a varus/valgus contracture of 15° and more. 7. The subject will be operated bilaterally. 8. The subject has an active or suspected latent infection in or about the knee joint. 9. Osteomyelitis 10. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 11. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 12. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 13. Female patients planning a pregnancy during the course of the study. 14. The patient is unable or unwilling to sign the Informed Consent specific to this study. Secondary exclusion criteria: when there are less than five tibia-bone markers or less than three insert markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study.
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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.
Contacts and locations
Locations
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Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
Hässleholm, 28138, Sweden
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Leiden University Medical Center
Leiden, 2300RC, Netherlands
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