Knee replacement showdown: cemented vs. uncemented implants under scrutiny
NCT ID NCT02525601
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two versions of the Triathlon total knee prosthesis—one fixed with bone cement and one without—in 60 people with knee osteoarthritis. Researchers will use special X-ray techniques to see how well each implant stays in place over time, and also track patients' pain, function, and satisfaction. The goal is to find out which method leads to better long-term outcomes and fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Triathlon total knee prosthesis (cemented and uncemented versions)
- What this could lead to
- If successful, this could help determine which type of knee implant (cemented or uncemented) provides better long-term stability and function for patients with osteoarthritis.
- What could go wrong
- This is a small, early-stage study with only 60 participants, so results may not apply to everyone. The main risk is that one implant type may loosen or fail over time, requiring revision surgery.
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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60 people
The number who actually took part.
- Started
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Mar 2009
- Expected to finish
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Dec 2026
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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18 to 85 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients suffering exclusively from osteo arthritis, Stage II-V \[Ahlbäck Trauma Score, 1968 391\] will be operated. 2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system 3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation. 4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery. Exclusion Criteria: 1. Previous major knee surgery 2. Other significant disabling problems from the muscular-skeletal system than in the knees 3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35). 4. Patients with active or suspected infection. 5. Patients with malignancy - active malignancy. 6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy. 7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. 9. Female patients planning a pregnancy during the course of the study. 10. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. 12. Patients with other severe concurrent joint involvements, which can affect their outcome. 13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis. 14. Patients under the protection of law (e.g. guardianship).
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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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Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm, Skåne County, 281 38, Sweden
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