Joint Disease
Conditions
Keywords
osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia, rheumatoid arthritis, correction of functional deformity, revision procedures
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® Gladiator HA Coated Modular Femoral Stem
Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem
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 Previously implanted bilateral subjects can have both THAs 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 Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component Survivorship | 10 years post-operative | The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient functional outcomes (hip specific) | 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval | To characterize total functional scores, as assessed by Hip disability and Osteoarthritis Outcome Scores (HOOS) |
| Patient functional outcomes (quality of life) | 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval | To characterize total functional scores, as assessed by EQ-5D-3L scores |
Countries
Belgium
Outcome results
None listed