Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

Launched by MICROPORT ORTHOPEDICS INC. · Jun 26, 2018

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be included in the study, subjects must meet all of the following criteria:
• * Has previously undergone primary Total Hip Arthroscopy for any of the following:
• • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
• • Inflammatory degenerative joint disease such as rheumatoid arthritis;
• • Correction of functional deformity
• • Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
• • Subject is willing and able to complete required study visits or assessments
• Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:
• • 1. the specified combination of components were implanted in both,
• • 2. all other aspects of the Inclusion/Exclusion Criteria are satisfied,
• • 3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
• • 4. the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.
• Exclusion Criteria:
• Subjects will be excluded if they meet any of the following criteria:
• • Subject was skeletally immature (less than 21 years of age) at time of implantation
• • Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
• • Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• • Subject is unwilling or unable to sign the Informed Consent document
• • Subject has documented substance abuse issues
• • Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• • Subject is currently incarcerated or has impending incarceration