Maxx Orthopedics' PCK Study
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|ClinicalTrials.gov Identifier: NCT03312088|
Recruitment Status : Not yet recruiting
First Posted : October 17, 2017
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment|
|Aseptic Loosening Infection Bone Loss MCL - Medial Collateral Ligament Rupture of the Knee Periprosthetic Fractures||Device: Freedom Knee PCK Components|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases|
|Estimated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
- Device: Freedom Knee PCK Components
Total Knee Revision
- Survivorship [ Time Frame: 36 months ]"No Explants"
- Revision rates of any component (including insert) for any reason. [ Time Frame: 36 months ]Revision rates of any component (including insert) for any reason.
- Revision rates of any component (including insert) for any reason except infection. [ Time Frame: 36 months ]Revision rates of any component (including insert) for any reason except infection.
- KSS [ Time Frame: 36 months ]Knee Society Score
- WOMAC [ Time Frame: 36 months ]Pain Score
- ROM [ Time Frame: 36 months ]Range of Motion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312088
|Contact: Gabriela Gottlieb, MPHfirstname.lastname@example.org|
|Contact: Kevin Phelps, CCRP||Kevin.Phelps@maxxortho.com|