Joint Disease
Conditions
Keywords
osteoarthritis, avascular necrosis, correction of functional deformity, painful hip dysplasia, protrusio acetabuli, rheumatoid arthritis, ankylosis
Brief summary
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.
Interventions
DEVICEPROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell
PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject 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
Exclusion criteria
* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery * Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component Survivorship | 10 years post-operative | The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient functional outcomes (hip specific) | Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval | To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores |
Countries
France
Outcome results
None listed