Status:
UNKNOWN
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
Lead Sponsor:
Maxx Orthopedics Inc
Conditions:
Aseptic Loosening
Infection
Eligibility:
All Genders
40-80 years
Brief Summary
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- The patient has a neuromuscular or neurosensory deficit.
- Female patients planning a pregnancy during the course of the study.
- Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- Varus or valgus deformity \> 20 degrees
- Bilateral TKR
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03312088
Start Date
January 1 2019
End Date
February 1 2022
Last Update
July 15 2021
Active Locations (1)
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1
Coastal Orthopedics
Bradenton, Florida, United States, 34209