Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

N/AActive Not RecruitingNCT02314702

MicroPort Orthopedics Inc.26 enrolled

Overview

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Joint Disease

Interventions

PROFEMUR® L Revision Femoral StemDEVICE

Revision Total Hip Arthroplasty

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has undergone revision total hip arthroplasty * Subject is implanted with the specified combination of components * Subject is willing and able to complete required study visits or assessments Exclusion Criteria: * Subjects currently enrolled in another clinical study * Subjects unwilling to sign the Informed Consent document * Subjects with substance abuse issues * Subjects who are incarcerated or have pending incarceration

Locations (1)

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Outcomes

Primary Outcomes

Number of participants who require a revision

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

Time frame: 10 years post-operative

Secondary Outcomes

Patient functional score on the the Oxford Hip Score instrument

To characterize patient hip-related health status, as assessed by Oxford Hip Scores

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

Patient functional score on the EQ-5D-3L instrument

To characterize patient general health status, as assessed by 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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