Persona SoluTion PPS Femur for Knee Replacement
This study is observing adults who are already planning to have a total knee replacement using the Persona® SoluTion® PPS femoral implant. The goal is to see how safe and effective this implant is in the US market. Researchers will look at how your knee function and pain improve after surgery, specifically by measuring changes in your KOOS JR score (a questionnaire about knee symptoms and function) between before surgery and two years later. This is an observational study, meaning you'll receive the standard treatment your doctor recommends. We don't have information on the current recruitment status, but the study plans to include 200 participants.
- Study design
- This is an observational study involving 200 participants. It is not a randomized trial, meaning participants will receive the Persona® SoluTion® PPS femoral implant as part of their planned total knee arthroplasty.
- What's involved
- You would need to complete scheduled follow-up evaluations as defined in the study protocol. The primary measurement is taken at two years post-operation.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least two years after their surgery to assess changes in their knee function.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Persona SoluTion PPS Femur PMCF
At a glance
Conditions
NCT07286513
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Denver Hip and Knee, Inc.
Denver, Coloradono site contact published
Medstar Health Research Institute
Baltimore, Marylandno site contact published
Norton Orthopedic Institute
Louisville, Kentuckyno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change in KOOS JR Score between pre-op and 2 years post-op2 years
A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function).