Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
NCT ID: NCT03312088
Last Updated: 2021-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2019-01-01
2022-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Freedom Knee PCK Components
Total Knee Revision
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
Yes
Sponsors
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Maxx Orthopedics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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David Cashin, MD
Role: PRINCIPAL_INVESTIGATOR
Coastal Orthopedics
Locations
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Coastal Orthopedics
Bradenton, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MO-2017-PCK
Identifier Type: -
Identifier Source: org_study_id
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