Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems

MicroPort Orthopedics Inc.75 enrolled

Overview

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.

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopaedic 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Joint Disease

Interventions

total hip arthroplasty implantDEVICE

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Component Survivorship

The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.

Time frame: 10 years post-operative

Secondary Outcomes

Patient functional outcomes

To characterize total functional scores, as assessed by Oxford Hip Scores and EQ-5D-3L scores

Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years

Data from ClinicalTrials.gov

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