Knee implant showdown: cemented vs cementless in new study
NCT ID NCT03522025
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of knee implants for people with knee osteoarthritis: one fixed with bone cement and one without. 70 participants will be randomly assigned to receive either a cemented or cementless implant. The goal is to see which type stays better fixed in the bone over 5 years, by checking for signs of loosening on X-rays.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- unicompartmental knee prosthesis (cemented or cementless design)
- What this could lead to
- If successful, this could help doctors choose the best type of knee implant for patients with knee osteoarthritis, potentially improving implant longevity and reducing complications.
- What could go wrong
- This is a small, early-stage study with only 70 participants, so results may not apply to everyone. The main focus is on implant fixation, not on curing the disease.
Why investors are watching
Medacta is testing whether its GMK-UNI knee prosthesis works better when fixed with cement or without cement in patients with knee osteoarthritis. For a small company, this 5-year, 70-patient randomized trial could shape which version surgeons choose and how the product is marketed.
If it works: A positive result showing one fixation method is clearly better could give Medacta a stronger sales story for that version of the knee implant. It might also help the company win over surgeons who are deciding between cemented and cementless options.
If it fails: The trial could show no meaningful difference between the two designs, or one design could perform worse, which would complicate the product line. Trials often fail or produce unclear results, and a delay or poor outcome could set back Medacta's plans without any guarantee of commercial benefit.
AI-written from the trial record. Speculative, and not investment advice.
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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70 people
The number who actually took part.
- Started
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Feb 2019
- Expected to finish
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Dec 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.
- Ages
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18 to 95 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: * Patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use according to Medacta implants included in this study (on-label use); * Those suffering from unilateral osteoarthritis or osteonecrosis of the medial compartment; * Frontal deformity \< 10° (evaluated on weight-bearing long-axis x-rays); * Flexion contracture \< 10°; * Intact ligaments; * Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery; * Patient's age over 18 years old; * Patient with BMI \< 40 kg/m2; * Patients must be willing to comply with the pre and post-operative evaluation schedule. Exclusion criteria: * Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study; * Any patient who cannot or will not provide informed consent for participation in the study; * Patients who need to undergo lateral unicompartmental knee arthroplasty; * Patients who need a revision surgery; * Patients who need a patella-femoral joint prosthesis; * Patients who had previously undergone high tibial osteotomy or ACL reconstruction; * Patients with BMI ≥ 40 kg/m2; * Patients unable to understand and take action; * Any case not described in the inclusion criteria; * Patients aged under 18 years;
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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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CHP Saint-Grégoire
Saint-Grégoire, France, 35760, France
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Centre Orthéo, Espace Fauriel
Saint-Etienne, France, 42100, France
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Clinique Saint Vincent de Paul
Bourgoin, France, 38300, France
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Clinique du Mail
La Rochelle, France, 17000, France
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Dr. Näder Helmy
Solothurn, Switzerland, 4500, Switzerland
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