Joint Disease
Conditions
Keywords
osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia, rheumatoid arthritis, correction of functional deformity, revision procedures
Brief summary
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA 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 MEDDEV 2.12/2 rev 2.
Detailed description
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.
Interventions
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
* Has undergone primary THA for any of the following: * Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia * Inflammatory degenerative joint disease such as rheumatoid arthritis * 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
* Skeletally immature (less than 21 years of age at time of 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 have pending incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component Survivorship | 10 years post-operative | The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient functional outcomes | Screening (First Available), 2-5 years, 5-7 years, and 10 years | The secondary objective is to characterize total functional scores, as assessed by HOOS Scores and EQ-5D-3L Scores. |
Countries
Canada
Outcome results
None listed