Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems

Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Inclusion Criteria:

• Subject previously underwent / is a candidate for 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 has been previously implanted / is a candidate to be implanted with the specified combination of components
• Subject is willing and able to complete required study visits or assessments
• Not previously implanted subject is able to undergo primary THA procedure

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

Prospective enrollment of a previously unimplanted contralateral hip is permitted in this study provided:

• it occurs not more than two years after the index THA
• the specified combination of components is used
• 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:

• Subject is skeletally immature (less than 21 years of age) at time of primary THA surgery
• Subject is currently enrolled in another clinical study which could affect the endpoints of this protocol
• Subject is unwilling to sign the Informed Consent document
• Subject has substance abuse issues
• Subject is incarcerated or has pending incarceration
• Subject is anticipated to require a contralateral THA less than 1 year after the index THA on the enrolled hip

In addition, not previously implanted subjects will be excluded if they meet any of the following criteria:

• Subject has any of the following contraindications at the time of implantation
• Overt infection
• Distant foci of infections (which may cause hematogenous spread to the implant site)
• Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram
• Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
• Neuropathic joints
• Hepatitis or HIV infection
• Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing