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Clinical Trials in the UK / NCT02314702
Active, not recruiting Observational

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

NCT02314702 · tracked via the Priya Life Science UK tracker
Sponsor
MicroPort Orthopedics Inc
Phase
Observational
Started
2015-09-04
Last updated
2022-10-13

Condition(s) studied

Joint Disease

Investigational drug(s) / intervention(s)

PROFEMUR® L Revision Femoral Stem

PROFEMUR® L Revision Femoral Stem: Revision Total Hip Arthroplasty

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants who require a revision — 10 years post-operative
    The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.

Trial sites (1)

FacilityCityRegionStatus
Royal Cornwall Hospital Truro Cornwall

More MicroPort Orthopedics Inc. trials in the UK

Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts Active, not recruiting
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert Enrolling by invitation

Other trials for the same condition

Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02314702 on ClinicalTrials.gov ↗ ← All trials in the UK