New study tests whether No-Cement knee implants outperform traditional ones
NCT ID NCT05630053
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of total knee replacement systems: one that uses cement to hold the implant in place and one that does not. Researchers will track 300 patients with knee pain from arthritis or deformity over 5 years to see which implant leads to better pain relief, function, and survival. The goal is to find out if the cementless version is a safe and effective alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Persona Knee System (cementless and cemented versions)
- What this could lead to
- If successful, this could show that a cementless knee replacement works as well or better than the cemented version, potentially offering a longer-lasting option with fewer complications.
- What could go wrong
- This is a mid-sized study comparing two existing devices, not a breakthrough treatment. Results may not apply to all patients, and there are standard surgical risks like infection or implant loosening.
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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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2032
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 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: 1. Patient is of legal age and skeletally mature 2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. Independent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling. Exclusion Criteria: 1. Patient is unwilling to sign the Informed Consent 2. Patient is currently participating in any other surgical intervention or pain management study 3. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients) 4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions 5. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study 6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 7. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty Study Device-Specific Exclusion Criteria: 8. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint 9. Insufficient bone stock on femoral or tibial surfaces. 10. Neuropathic arthropathy 11. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 12. A stable, painless arthrodesis in a satisfactory functional position 13. Severe instability secondary to the absence of collateral ligament integrity 14. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 15. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency
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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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Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306, United States
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Centura Health
Westminster, Colorado, 80023, United States
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Johns Hopkins University
Baltimore, Maryland, 21224, United States
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Lehigh Valley Hospital - Dickson City
Dickson City, Pennsylvania, 18519, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Oregon Health & Science University
Portland, Oregon, 972329, United States
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Rothman Institute
Bryn Mawr, Pennsylvania, 19010, United States
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