Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/30/2018 |
| Start Date: | July 2015 |
| End Date: | April 2029 |
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) European Union (EU) .
These types of studies are required by regulatory authorities for all THA devices that do not
have 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.
evaluate the safety and efficacy of its total hip arthroplasty (THA) European Union (EU) .
These types of studies are required by regulatory authorities for all THA devices that do not
have 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.
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
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) 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 have pending incarceration
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