Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship (NCT03312088) | Clinical Trial Compass
UnknownNot Applicable
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
United States300 participantsStarted 2019-01-01
Plain-language summary
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total KneeĀ® PCK System.
Who can participate
Age range40 Years ā 80 Years
SexALL
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Inclusion Criteria:
* Male and female subjects aged 40 years of age or older and less than 80 years of age (\>40 and \<80 years).
* 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.
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation.
* Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Exclusion Criteria:
* Primary knee replacement of the affected knee joint
* Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, neuropathic joints)
* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
* Patients who are found to be non-compliant by their physician
* Patients with or having; malignancy - active malignancy, active or suspected systemic infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
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