PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Launched by MICROPORT ORTHOPEDICS INC. · Jul 1, 2016

Keywords

ClinConnect Summary

This clinical trial, called the PMCF Study, is looking at the safety and effectiveness of certain hip replacement parts made by MicroPort Orthopedics (MPO) used in total hip surgeries. These studies are important because they help ensure that the devices are safe for patients, especially when there isn't enough long-term information available about them yet. The trial is currently active but not recruiting new participants.

To be eligible for the study, participants must have had hip replacement surgery due to various types of joint diseases, such as arthritis or other conditions affecting the hip. They should also have received specific components from MPO during their surgery. Participants will need to attend follow-up visits to assess their progress. It's important to note that individuals with certain types of hip implants or those involved in other clinical studies cannot join this trial. If you think you might be eligible or have questions about participating, it's a good idea to talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Has undergone primary THA 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; or
• • Correction of functional deformity
• • Subject is implanted with the specified combination of components
• • Subject is willing and able to complete required study visits or assessments
• Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
• • the specified combination of components were implanted in both
• • all other aspects of the Inclusion/Exclusion Criteria are satisfied
• • enrollment does not exceed the subject count specified in the Clinical Trial Agreement
• • the subject agrees to a second Informed Consent document specific to the second THA.
• Exclusion Criteria:
• • Subjects implanted with a metal-on-metal articulation
• • Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA
• • Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
• • Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
• • Subjects unwilling to sign the Informed Consent document
• • Subjects with substance abuse issues
• • Subjects who are incarcerated or having pending incarceration