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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →Maxx Orthopedics Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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Maxx Orthopedics Inc