New knee implant tested for better mobility and less pain
NCT ID NCT07286513
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 5 times
Summary
This study is testing a new knee implant called the Persona SoluTion PPS femur in 200 adults who need total knee replacement. The goal is to see if it safely improves knee function and reduces pain over two years. Participants will have their knee health measured before surgery and at follow-up visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Persona® SoluTion® PPS femoral implant (a knee replacement device)
- What this could lead to
- If successful, this could confirm that the implant improves knee function and reduces pain for people with arthritis or knee damage.
- What could go wrong
- This is a post-market study, not a new treatment. Results may not apply to all patients, and risks like infection or implant failure remain possible.
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2037
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.
Who is studied
The study population should be a consecutive series of subjects implanted with the Persona® SoluTion® PPS Femurs along with the corresponding Vivacit-E polyethylene articulating surface that meet the inclusion and exclusion criteria. To avoid selection bias, each Investigator will prospectively offer study participation to each consecutive potential and eligible patient for primary TKA using the commercially available Persona® SoluTion device. Bilateral patients requiring simultaneous surgical treatment will not be included in this study.
- 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 of consent 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. Patient qualifies for total knee arthroplasty based upon physical exam and medical history and meets the approved indications for use of the Persona® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort). 5. A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research Exclusion Criteria: 1. Patient is currently participating in any other surgical intervention or pain management study 2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent) 3. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions 4. 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 5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation 6. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint 7. Insufficient bone stock on femoral or tibial surfaces 8. Skeletal immaturity 9. Neuropathic arthropathy 10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb 11. A stable, painless arthrodesis in a satisfactory functional position 12. Severe instability secondary to the absence of collateral ligament integrity 13. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 14. Study device not implanted during surgery, or surgery did not occur 15. KOOS JR score not collected pre-operatively 16. Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Denver Hip and Knee, Inc.
Denver, Colorado, 80134, United States
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Medstar Health Research Institute
Baltimore, Maryland, 21218, United States
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Norton Orthopedic Institute
Louisville, Kentucky, 40241, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One shot in the knee: can hyaluronic acid quiet osteoarthritis pain?
- Could a simple wrist injection silence arthritis pain?
- Can a smaller cut in robotic knee surgery mean less pain and faster healing?
- Can a new shoulder implant restore arm function where others fail?
- One shot, one year: could a single injection ease knee arthritis pain?
- Can hip exercises protect knee cartilage in osteoarthritis?