Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM (NCT01529099) | Clinical Trial Compass
CompletedPhase 4
Postmarketing Study to Determine Performance of the SIGMA HP® PARTIAL KNEE SYSTEM
Italy, Switzerland64 participantsStarted 2009-01
Plain-language summary
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Male or female subjects, aged at least 21 years.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
* Subjects, who, in the opinion of the Clinical 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.
* Subject has non-inflammatory degenerative joint disease (NIDJD), including: osteoarthritis, posttraumatic arthritis, avascular necrosis and chondrocalcinosis.
* Subject has a functional stable knee.
* Subject, in the opinion of the Investigator, is suitable for either a single or bicompartmental knee replacement.
* Subject meets the following selected radiographic parameters:
* X-ray evaluation confirms the presence of NIDJD
* Disease location: 1 to 2 compartments, maximum. Disease can be present in the patellofemoral compartment, the medial tibiofemoral compartment, lateral tibiofemoral compartments alone or in any two compartments.
* Disease severity: Kellgren and Lawrence44 Grade II or greater for all compartments replaced.
Exclusion Criteria:
* Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or …