An observational study in Aseptic Loosening, Infection and Bone Loss, sponsored by Maxx Orthopedics Inc. Status unknown at 1 site in United States. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-15.
Sponsored by Maxx Orthopedics Inc · Observational
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.
The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.
An interim report will be issued when at least 120 patients will complete the 12-month follow-up.
No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.
Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
Exclusion Criteria:
Total Knee Revision
Survivorship
"No Explants"
Time frame: 36 months
Revision rates of any component (including insert) for any reason.
Revision rates of any component (including insert) for any reason.
Time frame: 36 months
Revision rates of any component (including insert) for any reason except infection.
Revision rates of any component (including insert) for any reason except infection.
Time frame: 36 months
KSS
Knee Society Score
Time frame: 36 months
WOMAC
Pain Score
Time frame: 36 months
ROM
Range of Motion
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maxx Orthopedics Inc